Identity
- Trade Name
- Cutiderm Hydrocolloid Extra Thin Wound Dressings 5cm x 5cm - Box of 10 EUDAMED
- Device Name
- Hydrocolloid Wound Dressings EUDAMED
- Model / Reference
- 83005 EUDAMED404.008004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958868782068 EUDAMED26958868782034 EUDAMED
- Basic UDI-DI
- B-16958868782068 EUDAMEDB-26958868782034 EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Hydrocolloid Wound 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-16958868782068 | 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 (3)
- EUDAMED b68c1966-9163-4484-961c-3d9f7cdd7e86 61 fields · synced Jul 28, 2026
- EUDAMED 80afded4-3182-4cf2-8ad2-358884ca9059 61 fields · synced May 19, 2026
- EUDAMED c79f92e2-03f3-4f14-84cf-59d3dccd57eb 61 fields · synced Jul 28, 2026