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Registry EUDAMED ~400 FDA 510(k) FDA PMA GUDID

Country / market European Union (all) ~400

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Germany ~359 Italy ~19 Austria ~9 Netherlands ~8 Czechia ~5

Risk class Class I ~400 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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Manufacturer: Ofa Bamberg GmbH× Clear all

Device · Manufacturer · Authorizations

Memory UDI-DI 04018839738755

Ofa Bamberg GmbH,Germany Class I

Active CE MDR EUDAMED I
3+ variants
- Memory 01824312D31200
- Memory 01816212840100
BELSANA classic E

Ofa Bamberg GmbH,Germany Class I

Active CE MDR EUDAMED I
Lastofa UDI-DI 04052727336685

Ofa Bamberg GmbH,Germany Class I

Active CE MDR EUDAMED I
8+ variants
- Lastofa 015301121205C0
- Lastofa 01510406144400
- Lastofa 01510408143420
- Lastofa 01520406560220
- Lastofa 01530108620110
- Lastofa 01540112653000
- Lastofa 01540414560220
Lastofa Baumwolle UDI-DI 04066177107634

Ofa Bamberg GmbH,Germany Class I

Active CE MDR EUDAMED I
2+ variants
- Lastofa Baumwolle 013447105602025
BELSANA comfortis UDI-DI 04018838413134

Ofa Bamberg GmbH,Germany Class I

Active CE MDR EUDAMED I
3+ variants
- BELSANA comfortis 21534106120400
- BELSANA comfortis 21534710140101
BELSANA classic UDI-DI 04018838135173

Ofa Bamberg GmbH,Germany Class I

Active CE MDR EUDAMED I
3+ variants
- BELSANA classic 215201102031C0
- BELSANA classic 215401149940C0

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