Identity
- Trade Name
- First Aid Kit-DIN 13164:2022 EUDAMEDFirst aid kit-13164 EUDAMEDFirst aid kit DIN 13164:2022 EUDAMED
- Device Name
- First Aid Kit EUDAMED
- Model / Reference
- 346.20 EUDAMED13164 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454722977 EUDAMED06951454780823 EUDAMED06951454767688 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-DIN 13164:2022 by Gauke Healthcare Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
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 (3)
- EUDAMED d8fe9c1c-b9c5-4c3d-a397-3a3ff9670091 61 fields · synced Oct 6, 2026
- EUDAMED b0cbc511-ed43-498a-aa9f-8cd33fb84a24 61 fields · synced Jul 11, 2026
- EUDAMED 76ed5f2d-c9e1-4a69-a767-71127755fd63 61 fields · synced Jul 20, 2026