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Sterile Burn Gels
EUDAMEDClass IIb (EU MDR)
Ref 403.034005Model Dressing typeRef 403.034008Ref 403.034006Model Gel type
Identity
- Device Name
- Sterile Burn Gels EUDAMED
- Model / Reference
- Dressing type EUDAMED403.034005 EUDAMED403.034008 EUDAMEDGel type EUDAMED403.034006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958868781030 EUDAMED16958868781061 EUDAMED16958868781047 EUDAMED
- Basic UDI-DI
- B-16958868781030 EUDAMEDB-16958868781061 EUDAMEDB-16958868781047 EUDAMED
- EMDN Code
- M04040501 HYDROGEL 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
Sterile Burn Gels 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-16958868781030 | 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 (3)
- EUDAMED 08d212d5-60f1-4732-a507-5796a208948a 61 fields · synced Jul 25, 2026
- EUDAMED 0bae2bcb-c05f-4a69-bb9b-2618e559f66c 61 fields · synced May 17, 2026
- EUDAMED 594814cf-2188-4bcb-99c0-ddd27a17325e 61 fields · synced May 19, 2026