Compressed gauze, 4, 5"x4, 1yd - 75m

EUDAMED

Class I (EU MDR)

Ref /

by GAUKE Healthcare Co., Ltd

Identity

Trade Name: Compressed gauze, 4,5"x4,1yd(11,43x3,75m) EUDAMED
Device Name: Absorbent cotton dressing EUDAMED
Model / Reference: / EUDAMED

Identifiers

Primary DI / UDI-DI: 06951454718857 EUDAMED
Basic UDI-DI: 69514547310UZ EUDAMED
EMDN Code: M020106 COTTON GAUZES IN PIECES EUDAMED
Models / Variants: 11 EUDAMED
43x3 EUDAMED
75m EUDAMED

Classification

Device Class: Class I EUDAMED
Market of Registration: Poland EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Compressed gauze, 4, 5"x4, 1yd - 75m by Gauke Healthcare Co., Ltd — Class I — MDR — listed in EUDAMED — 3 models — regulatory data on deviCERTS

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	69514547310UZ	Class I	Active

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Manufacturer

Manufacturer: GAUKE Healthcare Co., Ltd
EUDAMED SRN: CN-MF-000013784
Authorised Representative: MedPath GmbH DE-AR-000000087

Sources (1)

EUDAMED 4da632e4-a814-4c24-ab88-ca8e162abc68 61 fields · synced Oct 6, 2026