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Registry EUDAMED ~2,000 FDA 510(k) FDA PMA GUDID

Country / market European Union (all) ~2,000

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Germany ~2,000

Risk class Class I ~2,000 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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Ecosana UDI-DI 04018839966011

Ofa Bamberg GmbH,Germany Class I

Active CE MDR EUDAMED I
1,000+ variants
- Ecosana 31460404564140
- Ecosana 31460404573140
- Ecosana 31460406204040
- Ecosana 31460408200210
- Ecosana 31460410561210
- Ecosana 31460414203210
- Ecosana 31464310201000
- Ecosana 31464312200200
- Ecosana 31470114570200
- Ecosana 31470404571010
- Ecosana 31470408573240
- Ecosana 31470412204110
- Ecosana 31470416203140
- Ecosana 31474116560000
- Ecosana 31474304570000
- Ecosana 31474308560100
- See all variants of this device
Ecosana Cotton UDI-DI 04052727879069

Ofa Bamberg GmbH,Germany Class I

Active CE MDR EUDAMED I
334 variants
- Ecosana Cotton 31270404204210
- See all variants of this device

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