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Tk

by Guangzhou T.K Medical instrument Co., Ltd. 35 variants

Ref FYG-FMModel FYG-L; FYG-M; FYG-S; FYG-MS; FYG-XS; FYG-XXS; FYG-FL; FYG-FM; FYG-FS.

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69378455FYG055013K Basic UDI-DI 06937845505107UDI-DIDate27 Feb 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Vacuum Bells
Model / Reference
FYG-L, FYG-M, FYG-S, FYG-MS, FYG-XS, FYG-XXS, FYG-FL, FYG-FM, FYG-FS.
Primary DI / UDI-DI
06937845505107
Basic UDI-DI
69378455FYG055013K
EMDN Code
Y060306 Thoracolumbar orthoses
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000010707
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Guangzhou T.K Medical instrument Co., Ltd.

  • Tk

    Class IIa

  • Tk

    Class IIa

  • Tk

    Class IIa

  • Tk

    Class I

  • Tk

    Class IIa

  • Tk

    Class IIa

See all devices from Guangzhou T.K Medical instrument Co., Ltd. →

Properties

Other properties (13)

  • Sterile: No
  • 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