Identity
- Trade Name
- Cutiderm Paraffin Gauze Dressing 7.5cm x 7.5cm - Box of 20 EUDAMED
- Device Name
- Cotton Burn Dressings EUDAMED
- Model / Reference
- 405.028004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958868783034 EUDAMED
- Basic UDI-DI
- B-16958868783034 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER 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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Cotton Burn Dressings by Roosin Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-16958868783034 | 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 5f1322b7-9ca9-45bb-8df9-fed86501894a 61 fields · synced Jun 18, 2026
- EUDAMED c1fcb2e9-2604-4634-91af-ac57b032cbeb 61 fields · synced Jun 11, 2026