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Cutiderm Silicone Foam Dressing 5cm x 5cm- Pack of 1
EUDAMEDClass IIb (EU MDR)
Ref 412.011003
Identity
- Trade Name
- Cutiderm Silicone Foam Dressing 5cm x 5cm- Pack of 1 EUDAMED
- Device Name
- Silicone Foam Dressing EUDAMED
- Model / Reference
- 412.011003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958868786011 EUDAMED
- Basic UDI-DI
- B-16958868786011 EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Cutiderm Silicone Foam Dressing 5cm x 5cm- Pack of 1 by Roosin Medical Co., Ltd. — Class IIb — 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-16958868786011 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Roosin Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000021163
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED c99df7d6-2e72-4602-93f4-b9ac3d589c13 61 fields · synced Jun 14, 2026