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First aid kit meet DIN13164-2022 standard
EUDAMEDClass I (EU MDR)
Ref 64BW000 + TOYOTA BAGRef 64BW000 + LEXUS BAG
Identity
- Trade Name
- First aid kit meet DIN13164-2022 standard EUDAMED
- Device Name
- First Aid Kit EUDAMED
- Model / Reference
- 64BW000 + TOYOTA BAG EUDAMED64BW000 + LEXUS BAG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454763192 EUDAMED06951454735755 EUDAMED
- Basic UDI-DI
- 69514547305V8 EUDAMED
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- For temporary treatment in case of accidental injury. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
First aid kit meet DIN13164-2022 standard by Gauke Healthcare 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 | 69514547305V8 | Class I | Active |
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Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-PR-000038433
Sources (2)
- EUDAMED c15c8d8d-eaf4-4274-9c4f-d250d8119a1a 61 fields · synced Oct 6, 2026
- EUDAMED ac3e99ee-88de-4662-b472-9bad667ebcd0 61 fields · synced May 19, 2026