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Refill FAK
EUDAMEDClass I (EU MDR)
Ref 4006583Model 1ST AID KIT REFILL - 24PCES
Identity
- Trade Name
- Refill FAK EUDAMED
- Device Name
- Refill FAK EUDAMED
- Model / Reference
- 1ST AID KIT REFILL - 24PCES EUDAMED4006583 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03583787628256 EUDAMED
- Basic UDI-DI
- B-03583787628256 EUDAMED
- EMDN Code
- V0501 CLINICAL EMERGENCY KITS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Refill FAK by RFX+CARE Manufacturing Co., Ltd. — Class I — 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-03583787628256 | Class I | 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 e97eb615-141c-4c0d-b160-dbc6b616b3a8 61 fields · synced Jun 18, 2026