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Burn Gel
EUDAMEDClass IIa (EU MDR)
Ref FA200-9161Model 2g 3.5g 4g 5g 10g 15g 20g 25g 30g 40g 50g etc Ref FA200-560561Model 3.5g
Identity
- Trade Name
- Burn Gel EUDAMEDGekas Burn gel EUDAMED
- Device Name
- Burn Gel EUDAMED
- Model / Reference
- 2g 3.5g 4g 5g 10g 15g 20g 25g 30g 40g 50g etc EUDAMEDFA200-9161 EUDAMED3.5g EUDAMEDFA200-560561 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820991617 EUDAMED05706636560561 EUDAMED
- Basic UDI-DI
- 69228209MDN12042A000046H6 EUDAMEDB-05706636560561 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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69228209MDN12042A000046H6 | Class IIa | Active |
| 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 (2)
- EUDAMED ddbbeecf-cde8-422f-a197-c49b14a7eb1d 61 fields · synced Jul 13, 2026
- EUDAMED 5f3f689a-111a-4b89-9ba7-1959e61f8508 61 fields · synced May 17, 2026