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Foam Dressings
EUDAMEDClass IIa (EU MDR)
Ref 413.015002Model Non-adhesive with PU Film
Identity
- Trade Name
- Cutiderm Foam Dressings Non Adherent 5cm x 5cm - Pack of 1 EUDAMED
- Device Name
- Foam Dressings EUDAMED
- Model / Reference
- Non-adhesive with PU Film EUDAMED413.015002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958868785014 EUDAMED
- Basic UDI-DI
- B-16958868785014 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-16958868785014 | 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 (2)
- EUDAMED 1255be27-959f-4d50-b508-e5aab89fcc36 61 fields · synced Jun 19, 2026
- EUDAMED f47d35d2-d1de-467b-b9ec-ba010a7be9f7 61 fields · synced Jun 19, 2026