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Tk

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

Ref EK-TM2RModel EK-L88L; EK-L88R; EK-M88L; EK-M88R; EK-T88L; EK-T88R;EK-TL2L; EK-TL2R; EK-TM2L;EK-TM2R

EMDN Y0699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69378455EK088001M5 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 23 Oct 2026

Device Name
Ear Correction Kits
Model / Reference
EK-L88L, EK-L88R, EK-M88L, EK-M88R, EK-T88L, EK-T88R, EK-TL2L, EK-TL2R, EK-TM2L, EK-TM2R
Primary DI / UDI-DI
06937845504551
Basic UDI-DI
69378455EK088001M5
EMDN Code
Y0699 External prostheses and orthoses - other
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 I

  • Tk

    Class I

  • 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 06937845504551|69378455EK088001M5 61 fields · synced 23 Oct 2026