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Pressed tampon bandage

by GAUKE Healthcare Co., Ltd

Ref /Model FB6, FB8

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69514547300UW Basic UDI-DI 06951454750451UDI-DIDate29 Sep 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
First Aid Dressing Bandage
Model / Reference
FB6, FB8, /
Primary DI / UDI-DI
06951454750451
Basic UDI-DI
69514547300UW
EMDN Code
M0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.)
Device Class
Class I
EU market of registration
Lithuania

Manufacturer details

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

Other devices from Gauke Healthcare Co., Ltd

See all devices from Gauke Healthcare Co., Ltd →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No