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First Aid Kit
EUDAMEDClass I (EU MDR)
Ref FK-05Model FK-02, FK-05, FK-07, FK-08, FK-09, FK-11, FK-13, FK-15Ref FK-08
Identity
- Device Name
- First Aid Kit EUDAMED
- Model / Reference
- FK-02, FK-05, FK-07, FK-08, FK-09, FK-11, FK-13, FK-15 EUDAMEDFK-05 EUDAMEDFK-08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974442050227 EUDAMED06974442050241 EUDAMED
- Basic UDI-DI
- 697444205FAK0019Q EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
First Aid Kit by Jiangsu Rixin Medical Equipment Co., Ltd. — Class I — 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 | 697444205FAK0019Q | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Rixin Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008761
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 4c69f163-0382-4aaf-a576-2465afe24448 61 fields · synced Jul 25, 2026
- EUDAMED 9b426c8f-ae34-4c29-8d2c-813d11a9dc9f 61 fields · synced May 18, 2026