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Tk

by Guangzhou T.K Medical instrument Co., Ltd. 111 variants

Ref T05-100-CTModel Model CH (Type: CH-Optical); Model CK (Type: CK-Optical)

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 25 Oct 2026. What this means

Overview

Discover the TK medical device, a Class IIa trocar with a proven track record of precision and safety. Developed in collaboration with MedNet EC-REP GmbH, this device is designed to provide optimal performance for various surgical applications.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69378455TRO04902BV Basic UDI-DI 06937845501970UDI-DIDate26 Feb 2025RegisteredStatusActive

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  • Withdrawn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
Trocars
Model / Reference
Model CH (Type: CH-Optical), Model CK (Type: CK-Optical), T05-100-CT
Primary DI / UDI-DI
06937845501970
Basic UDI-DI
69378455TRO04902BV
EMDN Code
K01010103 Optical trocar, single-use
Device Class
Class IIa
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

  • 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