Identity
- Trade Name
- DIN13164:2022 Trio Kit EUDAMED
- Device Name
- First Aid Kit EUDAMED
- Model / Reference
- AL-0468 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454705048 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
DIN13164:2022 Trio Kit 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.
- AUTOMOTIVE KIT DIN13164-2022 in 2 PE bag — Bestreat Safety & First Aid Solution Co., Ltd. · Class I
- BE COMBIKIT BLACK (Gdh+Vest+verbandset) — Hubei V-Medical Products Co.,Ltd. · Class I
- VERBANDDOOS LEGAAL JODIMA-ref 10.0046 compleet — Hubei V-Medical Products Co.,Ltd. · Class I
- Combi-bag PLUS FILLING, Shrink Foil pack-C3-2050 — Bestreat Safety & First Aid Solution Co., Ltd. · Class I
- PHARMACAR RED BAG — Bestreat Safety & First Aid Solution Co., Ltd. · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-PR-000038433
Sources (1)
- EUDAMED cb3356f0-534a-4892-9c42-14517a3af0d0 61 fields · synced Jun 18, 2026