Opgen, Inc. - BEUDAMED

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101 results · 62ms · Sources: EU EUDAMED, US FDA

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FDA UDI 59 FDA registration 14 FDA 510(k) 10 Basic UDI-DI 4 Device 4 Importer 4 Authorized representative 2 Certificate 2 FDA classification 1 Manufacturer 1 + More Filters

Country

United States 61 Canada 29 Australia 5 Netherlands 3 Germany 2 Poland 1 + More Countries

Manufacturer

Opsens Inc. 14 Daan Gene Co., Ltd. 2 Qx Medical, Llc 2 W.H.P.M. Bioresearch & Technology Co., Ltd. 2 1drop Inc. 1 3 D Systems, Inc. 1 6over6 Vision Ltd 1 91330421 Ma28 A3 Ja37 1 A.Titan Instruments 1 Ace Surgical Supply Co., Inc. 1 Ach Medical Co., Ltd. 1 Acon Laboratories, Inc. 1 Addon Optics Ltd 1 Airway Manangement Inc 1 Apacor Limited 1 Arsci Inc. 1 Ast Vision Care Inc. 1 At&M Biomaterials Co., Ltd. 1 Avecena Gloves Sdn. Bhd. 1 A Vi Ta Corporation 1 + More Manufacturers

Competent Authority

De/Ca09 Staatliches Gewerbeaufsichtsamt Hannover 12 Ministry Of Health, Welfare And Sports 3 De/Ca21 Bezirksregierung Köln Dezernat 24 1 The Office For Registration Of Medicinal Products, Medical Devices And Biocidal Products 1 + More Competent Authorities

Kind

Active 2 Measuring Function 2 Single Use 2 Sterile 2 + More Kinds

Classification

FDA Class 2 10 Eu Md Class 2b 4 Eu Md Class 3 4 FDA Class 1 1 + More Classifications

Notified Body

Bsi Group The Netherlands B.V. 11 + More Notified Bodies

FDA FEI Number

3008061490 18 1000114185 9 1000117748 9 1000121056 9 1000138054 9 1000139754 9 1000306431 9 1043214 9 1721686 9 2011171 9 2024168 9 2124215 9 2183744 9 2939520 9 3000126629 9 3000717902 9 3002095335 9 3002287318 9 3002806565 9 3002807095 9 + More FDA FEI Numbers

Regulation

Us FDA 84 Eu Mdd 8 + More Regulations

Authorized Representative

Mdss Gmb H 11 + More Authorized Representatives

FDA Registration Number

3008061490 18 1000121056 9 1043214 9 1054811 9 1319639 9 1644312 9 1721686 9 2011171 9 2024168 9 2029275 9 2124215 9 2133928 9 2134265 9 2134285 9 2183744 9 2184149 9 2939520 9 3000126629 9 3004091615 9 3004111573 9 + More FDA Registration Numbers

Certificate Type

Mdd Annex Ii (Excluding Section 4) 11 + More Certificate Types

Status

On The Market 4 + More Statuses

Lotus NL B.V.

Authorized representative

🇳🇱 Netherlands·584 Manufacturers·21427 Devices

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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