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Non-Sterile Gauze Swabs

EUDAMED

Class I (EU MDR)

Ref MD304

by GAUKE Healthcare Co., Ltd

Identity

Trade Name
NON-STERILE GAUZE SWABS EUDAMED
Device Name
Absorbent non woven Compress EUDAMED
Model / Reference
MD304 EUDAMED

Identifiers

Primary DI / UDI-DI
06951454754473 EUDAMED
Basic UDI-DI
69514547317VF EUDAMED
EMDN Code
M040204 NON-ADHERENT ABSORBENT DRESSINGS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Ireland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Non-Sterile Gauze Swabs by Gauke Healthcare Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000013784
Authorised Representative
MedPath GmbH DE-AR-000000087

Sources (1)

  • EUDAMED ee808783-d029-4081-8848-e7c5745b80e4 61 fields · synced Oct 7, 2026