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Burn Gel&Dressing Kit
EUDAMEDClass IIb (EU MDR)
Ref BK001Model Dressing type/Gel type
Identity
- Trade Name
- Burn Gel&Dressing Kit EUDAMED
- Device Name
- Sterile Burn Gel EUDAMED
- Model / Reference
- Dressing type/Gel type EUDAMEDBK001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958868781337 EUDAMED
- Basic UDI-DI
- B-16958868781337 EUDAMED
- EMDN Code
- M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Norway 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
Burn Gel&Dressing Kit 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-16958868781337 | 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 dea1a610-23ac-4682-9d6d-202d55dce71b 61 fields · synced Jul 24, 2026