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Registry EUDAMED 13 FDA 510(k) FDA PMA GUDID

Country / market European Union (all) 13

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Germany 8 Netherlands 5

Risk class Class I 13 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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13 devices foundsorted by relevance

Manufacturer: Nea International BV× Clear all

Device · Manufacturer · Authorizations

Push ortho Hand Orthese DPT Base Part UDI-DI 08715669009449

Nea International BV,Netherlands Class I

Active CE MDR EUDAMED I
5 variants
- Push ortho Hand Orthese DPT Base Part 3.10.3.12
- Push ortho Hand Orthese DPT Base Part 3.10.3.13
- Push ortho Hand Orthese DPT Base Part 3.10.3.21
- Push ortho Hand Orthese DPT Base Part 3.10.3.22
Push UDI-DI 08715669004734

Nea International BV,Netherlands Class I

Active CE MDR EUDAMED I
5 variants
- Push 3.10.1.10
- Push 3.10.1.20
- Push 3.10.1.21
- Push 3.10.1.23
Push ortho Hand Orthese DPT Finger Part UDI-DI 08715669009463

Nea International BV,Netherlands Class I

Active CE MDR EUDAMED I
3 variants
- Push ortho Hand Orthese DPT Finger Part 3.10.4.01
- Push ortho Hand Orthese DPT Finger Part 3.10.4.03

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