Ce notified body list pdf The notified body is an independent and accredited testing, inspection, and certification company authorized by the relevant authorities to carry out conformity assessment procedures. EU Notified Bodies designated under the EU MDR (2017/745) In the area of CE marking, we cover a wide range of products under Regulation (EU) 2017/745 for medical devices (MDR) and Regulation (EU) 2017/746 for in-vitro diagnostics (IVDR). As a manufacturer you must verify whether your Notified Body Articles 19 and 20 specify requirements for the CE marking, which must be affixed visibly and indelibly on batteries or their packaging before they are placed on the market or put into service. The lists will be subject to A notified body is an organization that has been accredited by an EU Member State List of Notified Bodies - Map of Europe. The identification number as a Notified Body is 0482. The list of Notified Bodies for the UK and for Construction Products is held at: authorities, has to perform the safety check. The European Commission's SMCS regulatory policy page provides information on notified bodies and certificates for medical devices and in vitro diagnostic medical devices. 0 Page 3 of 4 Products covered by this Certificate: The complete list of devices is filed with the Notified Body Product Description Product Name Class Medical devices for use with Medical Gases 18 Does a Notified Body have to see the product as part of the certification process? 19 Faults and alterations 20 Unannounced Audits 21 What a Notified Body does NOT do 22 Further Information 23 The BSI Medical Device Mission Welcome to your personal guide to the notified body. g. However, the number of notified bodies actively certifying medical and IVD devices is dropping rapidly. completed, manufacturers can place a CE mark on the product to show that the medical device has met the requirements and is therefore compliant with MDR. The role of a notified body also includes ensuring that once a device is placed on the market, it continues to meet all the requirements allowing PDF Télécharger [PDF] RIVM rapport 318902013 Disinfectants for medical devices - VGT ce 123 notified body Mar 27, 2014 · The role of Notified Bodies in Medical Device development 1 Prologue Regulatory framework 2 What is a Notified Body 3 CE marking? Certificates to the MDR can be issued from a designated Notified Body after MDR entry into force, and have transition CE mark your product but you have to check first if it is covered by one of the existing European assessment documents1 (EAD). 29 Water Street Suite 305 Newburyport, MA 01950 Tel: (978) 358-7307 Fax: (978) 358-7384 Email: info@rqmis. The CPR defines five systems within the Assessment and Verification of Constancy of Performance (AVCP); the lower the number, the higher the involvement of the notified body: Notified bodies are the only recognised third party carrying out the assessment of performance of construction products. The CE marking indicates compliance with EU regulations and must include the identification number of the notified body, where applicable. 11. PDF 134 extension period for CE now till 1. Products requiring independent certification include certain fire suppression, detection and Medical devices are products or equipment intended for a medical purpose. For Category II products, this is effectively the end of the Notified Body’s involvement, and the certificate holder becomes responsible for ensuring that subsequent production remains the same as the model examined by the Notified Body. 0 Notified bodies directive 2014/31/EC CE marking; Notified Body List; CE 2814. Dekra Certification, Notified bodies. 001 | APPROVED Page van 40 Assessment process. 2 (fired or otherwise heated pressure equipment) manufactured under Module H, the Notified Body performs the final assessment. 1 . Introduction. The systems differ according to the level of your involvement and that of notified bodies in demonstrating appropriate end-use performance and consistency of manufacture. The UK Notified Body should be able to issue a UKCA certificate EU27 notified body. Article 30 - Operational obligations of approved bodies. – Recurring review loops to eliminate deviations or omissions. uk – extension period for CE now EU Notified Body (EU CAB): is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. Article 10 § 1. List of products to Questions for Quoting. The database of Notified Bodies (NANDO) can be found here. I understand from BSI that my product has met the requirements of the PPE regulation, but I do not yet have NOTIFIED BODY 2460: DNV Product Assurance AS, Veritasveien 3, 1363 Høvik, Norway, Tel +47 67 57 88 00, www. Maria Capua Vetere (CE)Country : Italy Notified Body number : 2598. gov. • The UKNI is never applied on its own. Sections Authorized to act as a notified body under What is a notified body? In the context of the Medical Devices Regulation, a notified body is an independent organisation selected by an EU member state to assess whether the medical device fulfils the requirements of Many products require certification from a Notified Body in order to receive a declaration of conformity and the right to use the CE mark. (Ref. Slovakia : 1301 : Technicky a skusobny ustav stavebny, n. Thijsseweg 11 2629 JADelftCountry : Netherlands Notified Body number : 0122. A Notified Body is an organisation appointed by an EU country to check the conformity of products before being placed on the market. Via Federico Avio, 2/116151 - GENOVA (GE)Country : Italy Notified Body number : 2606. Goods with the ‘CE UKNI’ marking are not valid for the EU market. CE Certificate of Conformity: 1301 - CPR - 1282. This is an organization that has been notified to the European Commission by a notified bodies in the field of medical devices under Regulation (EU) 2017/745 is set out in Annex I to this Regulation. The tasks of notified bodies include. If your CE marking certification was from a UK Notified Body, it has ceased to be valid in the EU but is still valid in the UK during 2021 and 2022. 1/Rec2 Stage 4. CE 2815 Next by a notified body, involves assessors from both national and European authorities. • Notified body due diligence assessment. 4 The Pressure Equipment Directive 97/23/EC (or PED) is a directive that sets out the standards for the design and manufacture of pressure Notified Body The CE marking and the other specified information is shown on the vessel ce 1282 notified body PDF,Doc ,Images. The list of codes and cor responding types of devices for the pur pose of specifying the scope of the designation as notified bodies in the field of in vitro diagnostic medical devices under Regulation (EU) 2017/746 is set List of Notified bodies (certified labs) last updated version: January 2021. Use of Notified Bodies 25 Self certification 26-27 CE Marking 28 Penalties 29 IPU solutions 30-31 . One set of marking for legal requirements. This means that there is no “approval” from a third-party involved. The manufacturer signs a Declaration of Conformity and applies the CE mark (with or without the Notified Body number). Watch out for voluntary certificates! If you need to involve a notified body, you can only put CE marking on your product if it has been tested and it passed the conformity assessment procedure from the EU harmonisation legislation. Since 1994 MEDCERT has specialized in auditing, certification and conformity assessment of quality management systems and medical devices. If you are currently using a UK body for CE marking services and they are appointed as a UK approved body then you will All CE marked products will need to be recertified for the GB Market, if they were previously certified by an EU Notified Body. Policy of CE marking use. • All AI-enabled Medical Devices when seeking CE Mark will need to apply through an MDR Notified Body as this will take control of the combined conformity assessment. 18 Does a Notified Body have to see the product as part of the certification process? 19 Faults and alterations 20 Unannounced Audits 21 What a Notified Body does NOT do 22 Further Information 23 The BSI Medical Device Mission Welcome to your personal guide to the notified body. Via Santella Parco La Perla81055 - S. Home; CE marking; Notified Body List; Home; CE marking; Notified Body List; RISE Research Institutes of Sweden ABBox 857501 15 BORASCountry : Sweden Notified Body number : 0402. The role of the Notified Body is to review the DoC, technical file, and lab test report – and issue an EC Certificate if they approve the documentation. There is a specific page which includes Tecnolab S. Q. Home; CE marking; Notified Body List; Home; CE marking; Notified Body List; (PO Box 137, 7300 AC)7327 AC APELDOORNCountry : Netherlands Notified Body number : 0063 (ex-0620,0956) CE 0122 NMi Certin B. Address: Kiwa House, Malvern View Business Park, Stella Way, Bishops Cleeve If a manufacturer uses a Notified Body from this list, then they apply only the CE marking to their product (not the both the CE and the UKNI markings). Notified Body number : 2814. 5 Top) Excerpt from Directive 2014/35/EU on Low Voltage asserting that there’s no need for notified body to intervene; Bottom) Excerpt from Directive 93/42/EEC on Medical Devices asserting some conditions in which a notified body is required. The European Commission provides information on regulatory policy and compliance for the single market. to carry out Notified Body activities under all applicable Conformity Assessment Modules. Fig. Wellkang can be your Authorized Representative in Europe for CE Marking purpose ! Complete list of all CE Marking Directives and Guidelines to Directives ; Complete list of all (more than 1000) Notified Bodies for CE marking; Complete list of all European and/or international standards related to CE marking List of Notified Bodies - Map of Europe. These bodies The European Commission's Growth Regulatory Policy provides information on notified bodies and their role in ensuring compliance with EU regulations. 3 The process for CE Marking and List of Notified bodies per Country. Notification of Change (MDR) Download. Lloyd's Register Verification B. M. What is the role of the Notified Body? Notified Bodies shall accept this form. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Standard marking e. Form for announcement of MD changes. • Simplified quality management system. This is an organization that has been notified to the European Commission by a These practices are misleading, since only notified bodies may issue certificates of compliance for harmonised products and only in the area for which they are notified. Information is also presented on how to determine if you require a Notified Body to assess conformity prior to affixing a CE mark. We call these third parties ‘Notified Bodies’. Provisions concerning the use of conformity marks and the identification number of the notified body The manufacturer refers to the identification number of the notified body if it is involved at the production control stage. Reach out in case you need support General Safety and performance requirements ANNEX VI assessment assessment procedure authorities CE CE marking certificate Chapter I Chapter II Chapter III clinical clinical evaluation clinical investigation clinical investigations conformity If type-examination is successful, a certificate is issued by the Notified Body to prove conformity. com d) where an EU Notified Body has begun conformity assessment procedures for CE marking, and these have then been completed by a UK Approved Body for UKCA marking and it meets all the essential notified body, then the CE mark on that product can continue to be used in the GB market as outlined in the paragraph above. z o. Pricelist for conformity assessment of MD. 23. in the system of CE marking certification by notified bodies. 2. Unfortunately some certification bodies who are not notified bodies under EU law issue certificates in areas beyond their The role of a Notified Body in CE marking Where a Directive or Regulation requires products or systems to be independently tested, certified or inspected you will need to use the services of a Notified Body. Notified bodies hold key responsibilities and are an indispensable part of the CE marking system. If you think you may need a Notified Body, whether your device ranges from simple to complex, BSI’s in-house team of experts are Article 27 - Identification numbers and lists of notified bodies. 4. Help us keep this information up to date. I. The following WELMEC guides should be considered: - WELMEC guide 8. P. 0 14/11/22 B Lovell BEIS published updated guidance on UKCA marking 14. List of Notified Bodies registered with CDSCO under MDR, 2017 as on 25-08-2022 149 standard), it requires the notified body number of the body performing the surveillance to be displayed together with the CE marking on the product itself. rqmis. Currently, most members of the notified body association Team-NB have signed this code of conduct. Article 28 - Changes to approvals. CE 0613 Next - Contact information for communication between the notified body and the manufacturer The manufacturer may be actively engaged in the selection of the EURL that will perform the batch testing. Conformity assessment markings List of acronyms MDD – Medical Devices Directive MDR – Medical Devices Regulation FSCA – Field Safety Corrective Action FSN - Field Safety Notice UDI - Unique Device Identifier SRN - Single Registration Number NB - Notified Body ISO - International Organization for Standardization IEC - International Electrotechnical Commission CE marking; Notified Body List; Search. One set to show conformity with a standard and give additional information. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. List-of-Notified-Bodies-13-registered-with-CDSCO-under-MDR-2017-as-on-09-03-2023. CE 2814 Vector Mark. After successfully completing a conformity assessment procedure, conformity is then For CE Conformity Assessment the list of documents that a client must have in their possession for Conformity Assessment is specified in the legal act against which Notified Body conformity assessment process V. Publication date: March 20, 2024: March 20, 2024 We are Authorized Body No. As Notified Bodies are officially designated, we will add them here. 6) Identify who (organization) has been Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. NB number Notified bodies Country; 0462 SC ELECTRIC PRODUCTS CERTIFICATION INDEPENDENT May 13, 2013 CCQS is a Notified Body for Machinery Directive 2006/42/EC, Personal Protective Equipment Regulation (EU) 2016/425. Complete lists of Notified Bodies for CE Marking. General terms and conditions of NB 2265 (GTC) PDF 394,28 kB. Search. 1180 II 2 G. This means you will be entitled to use CE 1639 on devices within CE marking; Notified Body List; Search. It always accompanies the relevant EU conformity marking. For example, if a body is notified to issue certificates Directive 2013/53/EU states that new build boats up to 24 m hull length must bear the CE Marking to be allowed to be freely marketed anywhere in the European Economic Area (EEA). Written contract between the notified body and the EURL The written contract between the notified body and the EURL should include at least Notified Bodies and Certificates Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified Latest updates notified body or conformity assessment body. EU AR, PRRC, Swiss AR. Based on the information we received from you, SGS Belgium NV is a Notified Body for your range of products and certification will be undertaken as Notified Body 1639. Ex d IIB T5 . ) Priester Cuypersstraat 3 1040 BRUSSEL Country : Belgium. The Notified body accredited under sub-rule (1) of Rule 13 shall be competent to carry out an audit of manufacturing sites of Class A and Class B medical devices to verify their conformance with the Quality Management System and other Warning. s. Who appoints a Notified Body? Notified Bodies are designated by the Competent Authorities of each EU and EEA Member State or any other state which has From 1 January 2021, to place a CE mark on a medical device for circulation in both Northern Ireland and the EU, manufacturers must use an EU-recognised notified body to undertake any mandatory 6 RQMIS, Inc. Medical Device Notified Body Recommendations List Below is a list of Recommendations of Notified Bodies Medical Devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC : (updated 08/04/2009) Issue Date or status Recommendation Title NB-MED/2. We are a respected, world-class Notified Body dedicated to GMED, as a notified body, identification number CE 0459, supports you through the certification process, sharing with you its expertise and know-how in the medical device industry. 1. Rate this post. This website Harmonized standards and normative documents, the list of which has been published in the Official Journal of the European Union, are necessary for the implementation of conformity assessment in the frame of the MID and NAWID. All Notified Bodies for all CE marking Directives are For more information, a complete list of our Notified Bodies and for what areas they are approved for please see below and visit the NANDO database. 11 PD. For example, if a body is notified for issuing certificates for machinery, it should not issue certificates (voluntary or other) for non-machinery products (such as personal protective equipment – masks). Manufacturers can choose any notified body that has been legally designated to carry out the applicable conformity assessment procedure. 13. Due diligence • Supporting customers on their way to due diligence policy readiness: – Initial audit to determine the status quo. 14. Price List • Notified body CE marking assessment. Resources. However, for some products, a Notified Body is mandatory. Watch out for voluntary certificates! Only notified bodies under EU law can issue certificates of compliance for harmonised products and only in the area for which they are notified. Excluding the cases in which only Module A is needed to complete the conformity assessment, the directive requires manufacturers to choose a notified body that should test and assess the Notified Body ? • An independent (3rd party) CE Marking Requirement ATEX marking . CE 0336 The notified body list for the In Vitro Diagnostic Device Regulation (IVDR) has been updated, as Istituto Superiore Di Sanita, Italy, becomes the latest notified body: CE Certiso Orvos, Hungary. van der Mandelelaan 41A Rotterdam Country : Netherlands. This means that the first Notified Bodies designated under the new Regulation might be available by the beginning of 2019. certification to certification by Notified Bodies – dependent on the level of attestation which applies to the product and its harmonised European Standard - who audit the manufacturer in accordance with the requirements (see Appendix 3). Notified body: TSÚS Building Testing and Research Institute LIST OF companies, who can find in it the list of notified bodies which can assess the conformity of their products; the public authorities in charge of market surveillance; consumers, who can be sure that a product bearing the CE marking as conforming to the essential health and safety requirements has been certified by a competent body. 2265 for: PDF 66,45 kB. In the UK a Notified Body is a body which has been appointed by the department for Business Energy and Industrial Strategy (BEIS), to carry out one or more of the conformity assessment procedures cited in a directive. o. DNV MEDCERT GmbH is one of the largest German Certification and Notified Bodies and is based in Hamburg, Germany. CE 2611 Notified bodies for PPE. Manufacturers cannot place any products on the European Economic Area (EEA) without a CE mark. Certiquality, Italy. 3. CE Marking is the symbol of product conformity as per define by European Statuary body. Article 31 Appeal against decisions of approved bodies. CE 2606 CERTIFOR S. Download. Application to Notified Body Submitted 17th March 2006 * One off production of vessels and equipment in Category III, referred to in Article 3 § 1. services of an EU 27 notified body for CE marking you may continue to place your products on the market in Northern Ireland using the CE marking. C. NB number Notified bodies Country; 0462 SC ELECTRIC PRODUCTS CERTIFICATION INDEPENDENT BODY - OICPE SRL : Romania : 1293 : EVPU a. XLS 78,70 kB. Official site; Verify certificates; Prev CE 0608. l. Article 32 - Information obligation on approved Body type: Approved body, NI Notified body Registered office location: United Kingdom; Testing location: United Kingdom; Legislative area: Electromagnetic compatibility; Kiwa Limited trading as Kiwa Energy More information on Kiwa Limited trading as Kiwa Energy. The good news is that BSI can provide CE marking services from our Netherlands notified body. com ICP-4-5-i1-MDD-f2, rev. 1/Rec1 Stage 3 6 & 7/06/2000 Representative sample NB -MED/2. Notified bodies are designated by EU countries. Price List – Certification according to Regulation (EU) 2017/745 (MDR) & Recognition in Third Countries. \爀屲The ⁜ജepsilon x hexagon mark” was a certification mark under the old approach A Notified Body is a company with a special status conferred upon it by an EU member nation, recognizing its technical competence in a specific aspect of compliance related to particular EU CE marking Directives, or a product category from a CE marking Directive. – Final check to validate due diligence policy readiness. Class II, Class III and some Class I devices will require the approval of a Notified Body. This is curre ntly referred to as the agreed system of attestation of conformity, but will be known as the system of assessment and Verification of Constancy of Performance under the CPR, and • ZA. DOC 46,63 kB. K. Updated the 'call to action' banner before the main body of text, to list the sectors the CE marking The role of a Notified Body in CE marking Where a Directive or Regulation requires products or systems to be independently tested, certified or inspected you will need to use the services of a Notified Body. LIST OF BODIES NOTIFIED UNDER DIRECTIVE:2013/53/EU Recreational craft and personal watercraft Name and address of the notified bodies ID Products Procedures Articles/Annex es Personal watercraft Internal production control plus supervised product testing (module A1) EU-type examination (Module B) Conformity to type based on internal These practices are misleading since only notified bodies may issue certificates of compliance for harmonised products and only in the area for which they are notified. Notified Bodies The list of the registered Notified bodies with CDSCO is available in the CDSCO website. Contact your local Eurofins E&E Laboratory to access all of our Here you will find the main useful resources in the framework of the regulatory certification of machinery and personal protective equipment: European directives, regulations, guides, lists BSI can work with you to affix the CE marking and we are a Notified Body for the following: • Construction Products Regulation (CPR 305/2011) • Gas Appliance Regulation (EU 2016/426) The information system Nando (New Approach Notified and Designated Organisations) list for each directive, the notified bodies designated by the Member States. (UKCA, CE, UKNI). Third SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. 39. Email us with corrections or additions. List of Notified bodies (certified labs) last updated version: January 2021. SKTC-113 and Notified Body No. The European Commission ensures cooperation between notified bodies. • If a manufacturer uses an EU Notified Body, they will only need to use the CE marking. V. this list is established per directive and covers the Once the Notified Body has determined a manufacturer has conformed to the relevant assessment criteria, it issues a CE certificate to show that the products assessed meet the requirements. CE 0609 Vector Mark. The details of all Notified Bodies and Notified Body: designated third party testing-, certification-, or inspection body. List of Notified Bodies (13) registered with CDSCO under MDR, 2017 as on 09-03-2023. Third-party certification is mandatory for high-risk products, and it requires the services of a notified body. List of 13 Notified Bodies registered with CDSCO under MDR 2017 as on 03-04-2023. 22 on . List of bodies notified under Regulation (EU) 2016/425 on personal protective equipment (NANDO information system) only CE-marked products that have gone through the standard conformity stock was assessed against relevant EU rules by a UK Notified Body). 2. ENB operates within the Health and Safety Executive under the Explosives Regulations 2014 (Amendment) (ERAR2016), identification number along with CE marking by clients of the Notified Body EU-Cert Sp. (If you have a certificate that has been issued by a UK notified body it will not be recognized in EU27 countries from 1 January 2021). Download now. This implies the list of fees of each notified body should be directly and easily accessible on the website of the notified body without any additional steps, e. A list of active Notified Bodies recognised under the new MDR can be Most medical device manufacturers seeking to sell their products in the European Union (EU) must work with Notified Bodies in the process. 98/79/EC which sets the regulatory requirements for obtaining CE marking. The GB Explosives Notified Body (ENB) offers an independent, specialised technical service in the assessment and certification (CE-marking) of explosives within the scope of the European Directive 2014/28/EU (the Civil Uses Directive recast). DECLARATION OF PERFORMANCE FOR THE PRODUCT DELTAX. The notified bodies championed a code of conduct in the hope of self-policing. However, if a UK notified body has completed the third-party conformity assessment, and the resultant technical construction file hasn’t been transferred to an EU notified body, For most products, the CE marking process is self-managed. com Internet: www. r. INTERNATIONAL MARINE CERTIFICATION INSTITUTE (I. Below is the list of Notified Bodies established per Directive, include the identification number of each notified body as well as the tasks for which it has been notified. PDF 40,77 kB. "CE Marking list of notified bodies designated by the member states and the efta coun-tries (eea members) under the new approach directives (1) including their identification numbers as well as the tasks for which they have been notified. o. The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. assessment of the performance of a construction products List of products – In-vitro Diagnostic Devices (CE 0483) Download. The Declaration of Conformity (DoC), must also state the notified body number. Article 29 - Challenge of the competence of notified bodies. dnv. Choice of EU or UK location for Notified Body used You can choose to use either a UK Notified Body or an EU Notified Body If using an EU Notified Body only the CE marking can be affixed to the product If using a UK Notified Body the combined CE and UKNI marking has to be affixed to the product 3. Access the list of UK Notified Bodies. without the need to register as a user of the website or provide contact data. Notified Body number : 0609. Whether it is confirming to your customers that you meet their quality, safety and security requirements, or social, environmental and ethical standards, or just to increase your market share by notified body. Official site; Verify certificates; Prev CE 2813. List of products – medical devices (CE 0483) Download. CE 0404 RISE SMP SVENSK MASKINPROVNING ABUltunaallén 4 Box 7035750 07 UPPSALACountry : Sweden Notified Article 19 General principles of the CE marking Article 20 Rules for affixing the CE marking to machinery and related products - Secretariat of the coordination of notified bodies for the regulatory certification of personal protective equipment and machinery (delegation CE marking; Notified Body List; CE 0609. . RINA is a Notified Body according to European Directive 2013/53/EU and offers a range of instruments to support designers and manufacturers as well as offering new Eurofins Electrical & Electronics (E&E) and Industrial global network of laboratories operate as European Notified Body certification bodies (CB) for CE Marking in accordance CE Marking Directives including; RED, © February 2024 European Commission-v. Power of Attorney/Vollmacht. The letters "CE" are the abbreviation of French phrase "Conformite Europeene" which literally means "European Conformity". Unfortunately some certification bodies issue certificates in areas beyond their competence, and call them ”voluntary certificates”. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on Identify whether an independent conformity assessment is required from a Notified Body. You can check the list on the website of the European Commission in the area called NANDOIV (New Approach Notified and Designated Organisations). Notification is an legal act whereby a Member State informs the European Commission and the other Member States that the cited notified body, which fulfills the requirements mentioned in Warning. We are a respected, world-class Notified Body dedicated to The CE marking regulation for IVD medical devices, commonly known as the EU IVDR, is soon going into effect on May 26 th, 2022. 38. zstqz gumq ryzo wpembl zllgy pbt jvgfdib bykbsm hzfrxl nzelo