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Gekas Family First Aid bag
EUDAMEDClass IIa (EU MDR)
Ref FA200-560516Model B001
Identity
- Trade Name
- Gekas Family First Aid bag EUDAMED
- Device Name
- First aid kit (B) EUDAMED
- Model / Reference
- B001 EUDAMEDFA200-560516 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05706636560516 EUDAMED
- Basic UDI-DI
- B-05706636560516 EUDAMED
- EMDN Code
- V0501 CLINICAL EMERGENCY KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
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
Gekas Family First Aid bag by RFX+CARE Manufacturing Co., Ltd. — Class IIa — 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-05706636560516 | 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 b2f82c54-a5f6-4bb7-af64-891fa10cbf1c 61 fields · synced Jun 19, 2026