K894480 - BEUDAMED

BEUDAMED

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1 results · 44ms · Sources: EU EUDAMED, US FDA

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Device 1 + More Filters

Country

China 1 + More Countries

Manufacturer

Sansure Biotech Inc. 1 + More Manufacturers

Competent Authority

Federal Agency For Medicines And Health Products / / Health Products Division 1 + More Competent Authorities

Kind

Single Use 1 + More Kinds

Classification

Eu Ivd General 1 + More Classifications

Regulation

Eu Ivdd 1 + More Regulations

Authorized Representative

Lotus Nl B.V. 1 Osen Gmb H 1 Obelis S.A. 1 + More Authorized Representatives

Status

On The Market 1 + More Statuses

H. PYLORI REAGENTS - OTHER

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·On the market

Data last updated 04 / 2026. Visit the official EUDAMED website for up-to-date data.

BEUDAMED

A better medical device search engine by OpenRegulatory.

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BEUDAMED

Rationale
MDR Notified Bodies
MDR Competent Authorities

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EU MDR

EU MDR Medical Devices EU MDR Active Medical Devices EU MDR Class I Medical Devices EU MDR Class I Software Devices EU MDR Class IIa Medical Devices EU MDR Class IIa Software Devices EU MDR Class IIb Medical Devices EU MDR Class IIb Software Devices EU MDR Class III Medical Devices EU MDR Class III Software Devices EU MDR Implantable Medical Devices EU MDR Measuring Function Medical Devices EU MDR Software Medical Devices

EU IVDR

EU IVDR In Vitro Diagnostic Devices EU IVDR Class A In Vitro Diagnostic Devices EU IVDR Class A Software Devices EU IVDR Class B In Vitro Diagnostic Devices EU IVDR Class B Software Devices EU IVDR Class C In Vitro Diagnostic Devices EU IVDR Class C Software Devices EU IVDR Class D In Vitro Diagnostic Devices EU IVDR Class D Software Devices EU IVDR Instrument Devices EU IVDR Kit Devices EU IVDR Reagent Devices EU IVDR Software Devices

FDA

FDA Medical Devices FDA Class I Medical Devices FDA Class II Medical Devices FDA Class III Medical Devices

By Country

EU IVDR Medical Devices from China EU IVDR Medical Devices from France EU IVDR Medical Devices from Germany EU IVDR Medical Devices from Romania EU IVDR Medical Devices from United States EU MDR Medical Devices from China EU MDR Medical Devices from Egypt EU MDR Medical Devices from Finland EU MDR Medical Devices from France EU MDR Medical Devices from Germany EU MDR Medical Devices from Italy EU MDR Medical Devices from Pakistan EU MDR Medical Devices from Poland EU MDR Medical Devices from Spain EU MDR Medical Devices from Türkiye EU MDR Medical Devices from United Kingdom EU MDR Medical Devices from United States

Notified Bodies

BSI Group The Netherlands B.V. DEKRA Certification B.V. DNV Product Assurance AS POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. SGS Belgium NV TÜV Rheinland LGA Products GmbH TÜV SÜD Product Service GmbH UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

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