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Tk

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

Ref T03-55-CT-S0, T05-100-BF, 2T052-CT-F, WP-90B, 2T102-BF-10T, HSD-40, T03-55-CT-S, 2T102-CT-F, 2T122-B3-12T, 3T52101-B3-10T, T03-70-BF, 5T521021-CT-DF, WP-200B, FYG-L, T10-150-CT-F, HSD-130, 3T52121-CT-F; 3T5212L1-CT-F, T10-100-A, HSD-40/S, HSD-60/F, HSD-130/A, FYG-FL, T10-150-CT, WP-280B, T15-150-CT, 4T52102-B3-10T, WP-330B, T12-100-CT-A, T05-150-CT, 2T102-CT-DF, T12-100-CT-DF, 2T052-75-CT-F, T05L-100-CT-D, 2T122-CT-F; 2T12L2-CT-F, 4T52122-CT-DF; 4T5212L2-CT-DF, WP-230B, T05-150-CT-DF, HSD-80/D, T05-150-CT-D, WP-35SC, 3T5L2101-CT-DF, T10-100-CT, HSD-100/F, WP-60TC, WP-60LC, 3T52121-CT-DF; 3T5212L1-CT-DF, T10-100-A-10T, 3T52101-CT-A, WP-60LTC, 3T52101-CT-DF, T05-75-CT-DFModel Model A; Model B; Model CH (Type CH-A, Type CH-S, Type CH-F); Model CK (Type CK-F), Model CH (Type: CH-Optical); Model CK (Type: CK-Optical), Model B, Model C, Model Standard; Model A; Model C, FYG-L; FYG-M; FYG-S; FYG-MS; FYG-XS; FYG-XXS; FYG-FL; FYG-FM; FYG-FS., Model S, Model D; Model F

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 Number69378455TRO04901BT Basic UDI-DI Date27 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  • Withdrawn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
Wound Protectors/Retractors
Retriever Bags
Vacuum Bells
Model / Reference
Model A, Model B, Model CH (Type CH-A, Type CH-S, Type CH-F), Model CK (Type CK-F), T03-55-CT-S0, T05-100-BF, Model CH (Type: CH-Optical), Model CK (Type: CK-Optical), 2T052-CT-F, Model C, WP-90B, 2T102-BF-10T, Model Standard, HSD-40, T03-55-CT-S, 2T102-CT-F, 2T122-B3-12T, 3T52101-B3-10T, T03-70-BF, 5T521021-CT-DF, WP-200B, FYG-L, FYG-M, FYG-S, FYG-MS, FYG-XS, FYG-XXS, FYG-FL, FYG-FM, FYG-FS., T10-150-CT-F, HSD-130, 3T52121-CT-F, 3T5212L1-CT-F, T10-100-A, Model S, HSD-40/S, Model D, Model F, HSD-60/F, HSD-130/A, T10-150-CT, WP-280B, T15-150-CT, 4T52102-B3-10T, WP-330B, T12-100-CT-A, T05-150-CT, 2T102-CT-DF, T12-100-CT-DF, 2T052-75-CT-F, T05L-100-CT-D, 2T122-CT-F, 2T12L2-CT-F, 4T52122-CT-DF, 4T5212L2-CT-DF, WP-230B, T05-150-CT-DF, HSD-80/D, T05-150-CT-D, WP-35SC, 3T5L2101-CT-DF, T10-100-CT, HSD-100/F, WP-60TC, WP-60LC, 3T52121-CT-DF, 3T5212L1-CT-DF, T10-100-A-10T, 3T52101-CT-A, WP-60LTC, 3T52101-CT-DF, T05-75-CT-DF
Primary DI / UDI-DI
06937845502939, 06937845500355, 06937845501864, 06937845501031, 06937845500737, 06937845500065, 06937845502274, 06937845503707, 06937845500867, 06937845500249, 06937845501307, 06937845503264, 06937845501093, 06937845502120, 06937845503615, 06937845500102, 06937845503417, 06937845500447, 06937845502298, 06937845503097, 06937845501536, 06937845505091, 06937845503660, 06937845502748, 06937845503691, 06937845500485, 06937845502755, 06937845501857, 06937845503653, 06937845502199, 06937845502175, 06937845503592, 06937845502236, 06937845503387, 06937845502540, 06937845502724, 06937845503752, 06937845503066, 06937845503813, 06937845501161, 06937845502205, 06937845501987, 06937845503110, 06937845501147, 06937845501185, 06937845502564, 06937845500454, 06937845502038, 06937845501192, 06937845504032, 06937845503745
Basic UDI-DI
69378455TRO04901BT, 69378455TRO04902BV, 69378455WP040001XC, 69378455HSD02101WY, 69378455FYG055013K, 69378455HSD02102X2, 69378455HSD02103X4
EMDN Code
K01010101, K01010103, K01020106, A090101, Y060306
Device Class
Class IIa
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

  • Sterile YesEUDAMEDNoEUDAMED

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