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Tk

by Guangzhou T.K Medical instrument Co., Ltd. China EUDAMED

Ref TK4K-CS01Model TK4K-CS01; TK4K-CS02

EMDN Z12020401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69378455TK4K109159 Basic UDI-DIDate21 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Endoscope Camera System
Model / Reference
TK4K-CS01, TK4K-CS02
Primary DI / UDI-DI
06937845504674
Basic UDI-DI
69378455TK4K109159
Direct Marketing DI
06937845504674
EMDN Code
Z12020401 Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images
Device Class
Class I
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 I

  • Tk

    Class IIa

  • Tk

    Class IIa

  • Tk

    Class I

  • Tk

    Class I

  • Tk

    Class I

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

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 06937845504674|69378455TK4K109159 61 fields · synced 24 Oct 2026