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DIN13164 First aid kits
EUDAMEDClass I (EU MDR)
Ref 10049Ref 023511Ref 10048Ref 10047
Identity
- Trade Name
- DIN13164 First aid kits EUDAMED
- Device Name
- First Aid Kit EUDAMED
- Model / Reference
- 10049 EUDAMED023511 EUDAMED10048 EUDAMED10047 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454718390 EUDAMED06951454740520 EUDAMED06951454780441 EUDAMED06951454710967 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
DIN13164 First aid kits 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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- Coil Pack - Essentials — Clonallon Laboratories Ltd · Class I
- DIN 13167-2014 (with nylon bag) — Hubei V-Medical Products Co.,Ltd. · Class I
- Einmal-Magillzange, groß, 25 cm, unsteril — Fuhrmann GmbH · Class IIa
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 (4)
- EUDAMED 8d66e135-5f30-4a97-ae53-9d65ab85f9b7 61 fields · synced Jul 31, 2026
- EUDAMED 9deb858f-ca1d-464b-9987-060f94aa8c6b 61 fields · synced May 18, 2026
- EUDAMED 0024a0f0-752b-44b2-b8ad-c13f37ce24f6 61 fields · synced May 18, 2026
- EUDAMED 7d9c5ca9-54c1-4461-baf9-1be40fbbd772 61 fields · synced May 19, 2026