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Burn Gel
EUDAMEDClass IIa (EU MDR)
Ref FA200-9154Model 2g 3.5g 4g 5g 10g 15g 20g 25g 30g 40g 50g etc
Identity
- Trade Name
- Burn Gel EUDAMED
- Device Name
- Burn Gel EUDAMED
- Model / Reference
- 2g 3.5g 4g 5g 10g 15g 20g 25g 30g 40g 50g etc EUDAMEDFA200-9154 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820991549 EUDAMED
- Basic UDI-DI
- 69228209MDN12042A000046H6 EUDAMED
- EMDN Code
- M0408 DRESSINGS FOR BURNS ONLY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Burn Gel by RFX+CARE Manufacturing Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69228209MDN12042A000046H6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- RFX+CARE Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000002971
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (1)
- EUDAMED d70511c9-1c68-410f-86e1-94574ed491a8 61 fields · synced Jun 18, 2026