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"Betriebsverbandkasten ultraWORKs ll DIN 13157:2021"

EUDAMED

Class I (EU MDR)

Ref SAN-0165

by GAUKE Healthcare Co., Ltd

Identity

Trade Name: "Betriebsverbandkasten ultraWORKs ll DIN 13157:2021" EUDAMED
Device Name: First Aid Kit EUDAMED
Model / Reference: SAN-0165 EUDAMED

Identifiers

Primary DI / UDI-DI: 06951454782827 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

"Betriebsverbandkasten ultraWORKs ll DIN 13157:2021" 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

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Manufacturer

Manufacturer: GAUKE Healthcare Co., Ltd
EUDAMED SRN: CN-PR-000038433

Sources (1)

EUDAMED 812d9b1a-7866-49ef-8787-379a88d1d97b 61 fields · synced Oct 6, 2026