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First aid kit with customized content list
EUDAMEDClass I (EU MDR)
Ref 020197Ref /
Identity
- Trade Name
- First aid kit with customized content list EUDAMED
- Device Name
- First Aid Kit EUDAMED
- Model / Reference
- 020197 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454722663 EUDAMED06951454768098 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
Category: Surgical retractor/retraction system blade, single-use
First aid kit with customized content list by Gauke Healthcare Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical retractor/retraction system blade, single-use.
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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 32e28af6-ddc0-40a8-8558-e7b72b2282e2 61 fields · synced Jul 14, 2026
- EUDAMED dd04b1ef-39ae-46b2-8e70-82a9f9eae3b3 61 fields · synced May 18, 2026