TRISTEL SOLUTIONS LIMITED - BEUDAMED

BEUDAMED

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82 results · 104ms · Sources: EU EUDAMED, US FDA

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Device 35 Basic UDI-DI 34 Importer 6 FDA UDI 3 Authorized representative 1 Certificate 1 FDA 510(k) 1 Manufacturer 1 + More Filters

Country

United States 3 Belgium 1 Cyprus 1 Denmark 1 Germany 1 Ireland 1 Norway 1 Sweden 1 United Kingdom 1 + More Countries

Manufacturer

Tristel Solutions Limited 77 Abionic Sa 3 Angio Dynamics Inc. 3 Clarius Mobile Health Corp. 3 Hunan Vathin Medical Instrument Co., Ltd. 3 Izi Medical Products 3 Kimal Plc 3 S&G Biotech Inc. (Seongnam Branch) 3 Sta Rmed Co., Ltd. 3 Shape Memory Medical Inc 3 Advanced Medical Solutions Ltd 2 Art Ventive Medical Group, Inc. 2 Bcm Co., Ltd. 2 Nouvag Ag 2 Scanlan International Inc. 2 Shenzhen Comen Medical Instruments Co.,Ltd. 2 Ac Cossor And Son (Surgical) Ltd 1 Apacor Limited 1 Adroit Medical Systems, Inc. 1 Alcor Scientific 1 + More Manufacturers

Competent Authority

Federal Agency For Medicines And Health Products / / Health Products Division 72 Cyprus Medical Devices Authority, Medical And Public Health Services, Ministry Of Health 1 De/Ca73 Landesamt Für Gesundheit Und Soziales Berlin 1 Danish Medicines Agency, Pharmacovigilance & Medical Devices 1 Health Products Regulatory Authority, Medical Devices Department 1 Swedish Medical Products Agency 1 The Norwegian Medical Products Agency 1 + More Competent Authorities

Kind

Single Use 30 Active 2 Sterile 2 + More Kinds

Classification

Eu Md Class 2b 38 Eu Md Class 1 19 Eu Md Class 2a 12 FDA Class 2 1 + More Classifications

Notified Body

Bsi Group The Netherlands B.V. 52 + More Notified Bodies

FDA FEI Number

2212018 1 3006892175 1 + More FDA FEI Numbers

Regulation

Eu Mdd 54 Eu Mdr 15 Us FDA 4 + More Regulations

Authorized Representative

Tristel Nv 71 + More Authorized Representatives

FDA Registration Number

2212018 1 3006892175 1 + More FDA Registration Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 52 + More Certificate Types

Status

On The Market 35 + More Statuses

Vingmed AB

🇸🇪 Sweden·25 Manufacturers

Vingmed A/S

🇩🇰 Denmark·27 Manufacturers

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

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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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