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DIN13164:2022 PLUS Car first aid bag

EUDAMED

Class I (EU MDR)

Ref AS 13164 NYLON

by GAUKE Healthcare Co., Ltd

Identity

Trade Name
DIN13164:2022 PLUS Car first aid bag EUDAMED
Device Name
First Aid Kit EUDAMED
Model / Reference
AS 13164 NYLON EUDAMED

Identifiers

Primary DI / UDI-DI
06951454730002 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 PLUS Car first aid bag 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.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-PR-000038433

Sources (1)

  • EUDAMED 34d26889-8618-470c-b5fd-6f27255e4f51 61 fields · synced Jul 23, 2026