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Registry EUDAMED 31 FDA 510(k) FDA PMA GUDID

Country / market European Union (all) 31

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Germany 31

Risk class Class I 31 Class IIa Class IIb Class III Class II (US)

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Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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31 devices foundsorted by relevance

Manufacturer: Dr. Berndsen GmbH× Clear all

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FaceFormer ZERO UDI-DI 04260582690426

Dr. Berndsen GmbH,Germany Class I

Active CE MDR EUDAMED I
12 variants
- FaceFormer ZERO DI-FFD-GB
- FaceFormer ZERO DI-FFD-GPT
- FaceFormer ZERO DI-FFD-GS
- FaceFormer ZERO DI-FFD-GW
- FaceFormer ZERO DI-FFG-BL
- FaceFormer ZERO DI-FFG-PR
- See all variants of this device
FaceFormer ONE clear UDI-DI 04260582690082

Dr. Berndsen GmbH,Germany Class I

Active CE MDR EUDAMED I
12 variants
- FaceFormer ONE clear DI-FF-KB
- FaceFormer ONE clear DI-FF-KPG
- FaceFormer ONE clear DI-FF-KPR
- FaceFormer ONE clear DI-FF-KPT
- FaceFormer ONE clear DI-FF-KW
- FaceFormer ONE clear DI-FFD-KPG
- FaceFormer ONE clear DI-FFD-KPT
- FaceFormer ONE clear DI-FFD-KS
- FaceFormer ONE clear DI-FFD-KW
- See all variants of this device
FaceFormer ONE blue UDI-DI 04260582690341

Dr. Berndsen GmbH,Germany Class I

Active CE MDR EUDAMED I
6 variants
- FaceFormer ONE blue DI-FF-BPG
- FaceFormer ONE blue DI-FF-BPT
- See all variants of this device

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