CE mark (with Notified Body #) N/A 0086 Indicates the European Conformity Mark with Notified Body Number. 0086 is the BSI-UK-registered Notified Body. Council Directive 93/42/EEC CE mark (with Notified Body #) N/A 2797 Indicates the European Conformity Mark with Notified Body Number. 2797 is the BSI-NL-registered Notified Body. Council Directive

2020-2-11 · A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states. Manufacturers can choose any notified body for conformity assessment …

CE marking The fast route to compliance in the European Union 2. CE marking What is CE marking? Products to be sold in the European Union (EU) that come under certain European Directives must bear the CE mark – it is a legal requirement. Please click the following links to learn more about every CE-Marking-related European Union Directive, Guidelines to Directives, Frameworks of implementation of Directives, and Agreements on Mutual Recognition of conformity assessment between European Union and other countries such as USA, Japan, Canada, Australia, New Zealand and Israel:- This results in CE marking with the number of the notified body responsible for the production follow-up next to the CE marking. The manufacturer is obliged to issue the EU Declaration of Conformity, which must accompany (at list via a weblink) the PPE, together with the instructions for use. Hi, Long time listener and first time caller.

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BSI Group The Netherlands B.V., registered in the Netherlands under number 33264284, at John M. bsi. By Royal Charter. EC Certificate - Full Quality Assurance. Directive 98/79/EC of BSI, a Notifled Body for the above Directive (Notified Body Number 2797):. 4 Sep 2019 An electronic certificate can be authenticated online. BSI Group The Netherlands B.V., registered in the Netherlands under number 33264284,  For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 2797):. Albert Roossien, Regulatory Lead.

18 Feb 2021 BSI will continue to offer CE marking services for EU27 market access via our Netherlands Notified Body (2797)³, as well as many other global  The MatOrtho ISO 13485 and CE marking certificates were previously issued by BSI Notified Body Number 2797 in The Netherlands in the EU is already  For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 2797):. Gary E Slack, Senior Vice President Medical Devices.

BSI Group The Netherlands B.V, Say Building. John M. Keynesplein 9, 1066 EP, Amsterdam, Netherlands. NB2797. This product was CE 

Information updated on December 13, 2018. EU – New notified body designated under the MDR – NB 2797 BSI Group The Netherlands B.V. Netherlands By Marcelo Antunes on November 6, 2019 NB 2797 – BSI Group The Netherlands B.V. – Netherlands Published in Medical Device Regulation MDR and Notified Body CE mark (with Notified Body #) N/A 0086 Indicates the European Conformity Mark with Notified Body Number. 0086 is the BSI-UK-registered Notified Body.

Notified body number 2797. EU (BSI) Test Report 3215330 This is an independent test and evaluation to certain sub clauses of the specification for BSI COVID 19 filtering face pieces, technical specification for BSI COVID 19 masks for use by healthcare workers.

EU Type Examination Certificate. This is to certify that: Holds Certificate Number: CE 690991. In respect (Notified Body Number 2797 ):. An electronic certificate can be authenticated online. BSI Group The Netherlands B.V., registered in the Netherlands under number 33264284, at John M. 8 Jul 2020 An electronic certificate can be authenticated online. BSI Group The Netherlands B.V., registered in the Netherlands under number 33264284,  CE 655935. Issued To: Novoxel the placing on the market of class III products an Annex II section 4 certificate is required.

This certificate has been issued by and remains the property of BSI Group The Netherlands B.V., John M. BSI Group The Netherlands B.V., registered in the Netherlands under number 33264284, at John M. (Notified Body Number 2797 ):. An electronic certificate can be authenticated online. BSI Group The Netherlands B.V., registered in the Netherlands under number 33264284, at John M. bsi. By Royal Charter.
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This is to certify that: Sunbeam CE 730303. In respect of: (Notified Body Number 2797):. Previous   Certificate of Conformity of the Factory Production Control 2797 CPR 616277 BSI Group The Netherlands B.V., registered in the Netherlands under number 33264284, at John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands.

BSI Group now has two entities, BSI UK with Notified Body number 0086 and BSI-NL with Notified Body number 2797. 2021-04-21 · EU – New notified body designated under the MDR – NB 2797 BSI Group The Netherlands B.V. Netherlands.
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The MatOrtho ISO 13485 and CE marking certificates were previously issued by BSI Notified Body Number 2797 in The Netherlands in the EU is already 

1066 EP Amsterdam. Please Note: This letter provides  For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 2797):. Gary E Slack, Senior Vice President Medical Devices.