TERUMO CORPORATION - BEUDAMED

BEUDAMED

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6,761 results · 74ms · Sources: EU EUDAMED, US FDA

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FDA UDI 6k FDA registration 200 FDA Pre-Market Approval 127 FDA 510(k) 65 Manufacturer 5 Importer 4 Certificate 3 Authorized representative 1 + More Filters

Country

United States 7k Canada 125 Japan 21 Philippines 13 Belgium 3 France 1 Ireland 1 + More Countries

Manufacturer

Terumo Corporation 7 Terumo (Philippines) Corporation 2 3 M Company 1 Air Water Realize Inc. 1 Andon Health Co., Ltd. 1 Anji Bofeng Medical Supplies Co., Ltd. 1 Bd Medical – Pharmaceutical Systems,Becton, Dickinson And Company 1 Baxter Healthcare Sa 1 Beijing Choice Electronic Technology Co., Ltd. 1 Beijing Hotgen Biotech Co., Ltd. 1 Blue Sail Medical Co., Ltd 1 Bolton Medical, Inc. 1 C A T Resources, Llc 1 Cmuk Visual Safety Ltd, Also Trading As Koolpak Ltd 1 Cu Medical Systems, Inc. 1 Changzhou Major Medical Products Co.,Ltd 1 Clement Clarke International Ltd 1 Clinisupplies Gb Limited 1 Conva Tec Limited 1 Covidien Llc 1 + More Manufacturers

Competent Authority

Federal Agency For Medicines And Health Products / / Health Products Division 11 Agence Nationale De Sécurité Du Médicament Et Des Produits De Santé 1 Health Products Regulatory Authority, Medical Devices Department 1 + More Competent Authorities

Classification

FDA Class 3 127 FDA Class 2 65 + More Classifications

Notified Body

Tüv Rheinland Lga Products Gmb H 5 + More Notified Bodies

FDA FEI Number

3008307705 265 2011171 183 2183744 162 3002807314 158 1000306431 131 3005747797 130 1016427 127 1721686 127 3003528016 127 2024168 126 3004091615 126 3004635528 126 3012102437 100 1118880 99 2182269 99 2243441 99 3000215205 99 3000215273 99 3002757549 99 3002827704 99 + More FDA FEI Numbers

Regulation

Us FDA 7k + More Regulations

Authorized Representative

Terumo Europe N.V. 8 + More Authorized Representatives

FDA Registration Number

3008307705 265 2011171 183 2183744 162 3002807314 158 2029275 131 3011137372 130 1016427 127 1721686 127 9616099 127 2024168 126 2939561 126 3004091615 126 3012102437 100 1118880 99 1226183 99 1423662 99 2134812 99 2182269 99 2243441 99 2953359 99 + More FDA Registration Numbers

Certificate Type

Mdr Qms 4 Ivdr Qms 2 + More Certificate Types

Radifocus Glidewire Advantage Track

FDA Class 2 ·Cardiovascular

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

BEUDAMED

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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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