Gekas Burn gel
by RFX+CARE Manufacturing Co., Ltd.
Ref FA200-560561Model 3.5g
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-05706636560561 05706636560561 | Date7 Jun 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Burn Gel
- Model / Reference
- 3.5g, FA200-560561
- Primary DI / UDI-DI
- 05706636560561
- Basic UDI-DI
- B-05706636560561
- EMDN Code
- M0408 Dressings for burns only
- Device Class
- Class IIa
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000002971
- Authorised representative
- RFX+Care International A/S DK-AR-000001768
Other devices from RFX+CARE Manufacturing Co., Ltd.
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No