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Cohesive Bandage

EUDAMED

Class I (EU MDR)

Ref 0161-050-ABSModel FB6, FB8Ref 0161-100-GLB Ref 0161-100-ALBRef 0161-150-NGR

by GAUKE Healthcare Co., Ltd

Identity

Trade Name
Cohesive Bandage EUDAMED
Device Name
First Aid Dressing Bandage EUDAMED
Model / Reference
FB6, FB8 EUDAMED
0161-050-ABS EUDAMED
0161-100-GLB EUDAMED
0161-100-ALB EUDAMED
0161-150-NGR EUDAMED

Identifiers

Primary DI / UDI-DI
06951454701019 EUDAMED
06951454700913 EUDAMED
06951454700982 EUDAMED
06951454700494 EUDAMED
Basic UDI-DI
69514547300UW EUDAMED
EMDN Code
M0303010103 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN TWO DIRECTIONS EUDAMED
M0303010203 ELASTIC FIXING BANDAGES, SELF-ADHESIVE, EXTENSIBLE IN TWO DIRECTIONS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Romania 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

Cohesive Bandage 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

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

Sources (4)

  • EUDAMED 69be1b93-3543-4050-8ce6-06b00fc31431 61 fields · synced Oct 6, 2026
  • EUDAMED 14a576da-5839-4110-8502-08878dd86f9e 61 fields · synced May 18, 2026
  • EUDAMED 35058e67-c7fd-458b-bcf2-3db92972df78 61 fields · synced May 19, 2026
  • EUDAMED 56cf320b-a9b1-431f-8034-f6ef303968fa 61 fields · synced Jul 28, 2026