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Burn Gel
EUDAMEDClass IIa (EU MDR)
Ref FA200-9158Model 2g 3.5g 4g 5g 10g 15g 20g 25g 30g 40g 50g etc Ref FA200-9163Ref FA200-9162Ref FA200-9159Ref FA200-9160
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 EUDAMEDFA200-9158 EUDAMEDFA200-9163 EUDAMEDFA200-9162 EUDAMEDFA200-9159 EUDAMEDFA200-9160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820991587 EUDAMED06922820991631 EUDAMED06922820991624 EUDAMED06922820991594 EUDAMED06922820991600 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 (5)
- EUDAMED e60e54a1-8e2d-42a7-888b-a830e836c133 61 fields · synced Oct 6, 2026
- EUDAMED 5bb7a131-957d-412c-bb12-a6d7fcf22ee7 61 fields · synced May 17, 2026
- EUDAMED 5ad56e8d-323a-4a28-b996-42bdd53fd6b0 61 fields · synced May 17, 2026
- EUDAMED 406b5070-571d-40df-b6ee-219ee376b10f 61 fields · synced May 18, 2026
- EUDAMED e3171a63-a2fb-4dc6-b2e5-ea4d70c262ca 61 fields · synced May 19, 2026