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Tk

by Guangzhou T.K Medical instrument Co., Ltd. 10 variants

Ref T05-100-CT-SModel Model A; Model B; Model CH (Type CH-A, Type CH-S, Type CH-F); Model CK (Type CK-F)

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06937845503844 UDI-DI Date27 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69378455TRO04901BT Basic UDI-DI 06937845503844UDI-DIDate27 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Tk EUDAMED
Gtk Trocars GUDID
Generic Name
Laparoscopic access cannula, single-use
Device Name
Trocars
Model / Reference
Model A EUDAMED
Model B EUDAMED
Model CH (Type CH-A EUDAMED
Type CH-S EUDAMED
Type CH-F) EUDAMED
Model CK (Type CK-F) EUDAMED
T05-100-CT-S EUDAMED
CT Bladeless Trocar GUDID
Primary DI / UDI-DI
06937845503844
Basic UDI-DI
69378455TRO04901BT
510(k) Number
FDA Product Code
GCJ
EMDN Code
K01010101 Trocar standard, single-use
GMDN Term
Laparoscopic access cannula, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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
  • Single Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No