Identity
- Trade Name
- Cutiderm EUDAMED
- Device Name
- Hydrophilic-Gel Exudate-Absorbent Dressings EUDAMED
- Model / Reference
- 402.046001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958868780002 EUDAMED
- Basic UDI-DI
- B-16958868780002 EUDAMED
- EMDN Code
- M04040201 ALGINATE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland 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 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-16958868780002 | 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 325697f3-9ad2-498f-a705-c7d48fe3e50f 61 fields · synced Jun 19, 2026