K061353 - BEUDAMED

BEUDAMED

⌘K

API Documentation Get API Key Sign in By OpenRegulatory ↗

21 results · 52ms · Sources: EU EUDAMED, US FDA

Filter by

FDA registration 14 FDA 510(k) 3 FDA classification 3 FDA UDI 1 + More Filters

Country

United States 15 China 6 + More Countries

Classification

FDA Class 2 6 + More Classifications

FDA FEI Number

1825034 4 2024024 4 3000207350 4 3000270450 4 3002808269 4 3003477135 4 3004049923 4 3004464325 4 3004719693 4 3006017180 4 3007923096 4 3008791302 4 3008812560 4 3008868758 4 3009417901 4 3015399803 4 3034676720 4 1000116116 3 1000125596 3 1000306431 3 + More FDA FEI Numbers

Regulation

Us FDA 21 + More Regulations

FDA Registration Number

1825034 4 2024024 4 2531195 4 3000270450 4 3003477135 4 3004049923 4 3004464325 4 3004719693 4 3006017180 4 3007923096 4 3008791302 4 3008812560 4 3008868758 4 3009417901 4 3015399803 4 3034676720 4 8043792 4 1000200989 2 1000432246 2 1000461041 2 + More FDA Registration Numbers

FDA K Number

K000009 1 K000273 1 K000464 1 K000486 1 K000513 1 K000536 1 K000634 1 K000742 1 K000851 1 K001178 1 K001272 1 K001353 1 K001357 1 K001794 1 K001844 1 K001847 1 K001864 1 K002268 1 K002371 1 K002592 1 + More FDA K Numbers

Enzyme Immunoassay, Opiates

FDA classification

FDA Class 2 ·Enzyme Immunoassay, Opiates

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

BEUDAMED

A better medical device search engine by OpenRegulatory.

API Documentation
API Dashboard
EUDAMED API on GitHub
Imprint

BEUDAMED

Rationale
MDR Notified Bodies
MDR Competent Authorities

OpenRegulatory

OpenRegulatory
Formwork eQMS Software
Digital Health Jobs
EUDAMED Budget Monitor
eidel.io

Tools

510(k) Predicate Finder
Product Code Directory
510(k) Review Times
21 CFR Regulations
NB Comparison

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.

© 2026 OpenReg GmbH. All rights reserved.