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Cotton Burn Dressings
EUDAMEDClass IIa (EU MDR)
Ref 405.068005Ref 505.100001Ref 405.028002
Identity
- Device Name
- Cotton Burn Dressings EUDAMED
- Model / Reference
- 405.068005 EUDAMED505.100001 EUDAMED405.028002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958868783072 EUDAMED16958868783102 EUDAMED16958868783010 EUDAMED
- Basic UDI-DI
- B-16958868783072 EUDAMEDB-16958868783102 EUDAMEDB-16958868783010 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDNorthern 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
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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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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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-16958868783072 | 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 555eda7c-5819-4f09-b5de-4900fbdbaefe 61 fields · synced Aug 2, 2026
- EUDAMED 2a8987b5-a1dc-48d1-b5f6-cc69ba1f7436 61 fields · synced May 18, 2026
- EUDAMED 33a4f293-d4bb-48b4-82d2-828b4809f743 61 fields · synced May 19, 2026