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Foam Dressings
EUDAMEDClass IIa (EU MDR)
Ref 413.015004Model Non-adhesive with PU FilmRef 413.015003Ref 413.015001
Identity
- Trade Name
- Cutiderm Foam Dressing 7.5x7.5cm - Pack of 1 EUDAMED
- Device Name
- Foam Dressings EUDAMED
- Model / Reference
- Non-adhesive with PU Film EUDAMED413.015004 EUDAMED413.015003 EUDAMED413.015001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958868785038 EUDAMED16958868785021 EUDAMED16958868785007 EUDAMED
- Basic UDI-DI
- B-16958868785038 EUDAMEDB-16958868785021 EUDAMEDB-16958868785007 EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Foam Dressings by Roosin Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16958868785038 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Roosin Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000021163
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (4)
- EUDAMED 2b83ac6d-daaf-4299-8f00-2bad00bc7869 61 fields · synced Jul 30, 2026
- EUDAMED 5b869efc-08ed-4232-bc10-0e7b46cc8c44 61 fields · synced May 17, 2026
- EUDAMED c62b146b-b4c1-41e1-9798-70efac12b387 61 fields · synced May 18, 2026
- EUDAMED 5a2e543e-7623-44e5-bd34-d36ccec64f9c 61 fields · synced Jul 9, 2026