Skip to content

Thymidine kinase 1 (TK1) Assay Kit (Chemiluminescent Immunoassay)

by Sino-Swed TongKang Bio-Tech (Shenzhen) Limited.

Ref /Model 50tests/box,100tests/box,200tests/box

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/IVDD NumberB-06974428170000 Basic UDI-DI 06974428170000UDI-DIDate9 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
50tests/box, 100tests/box, 200tests/box, /
Primary DI / UDI-DI
06974428170000
Basic UDI-DI
B-06974428170000
EMDN Code
W0102039008 Thymidine kinase
Device Class
Class IVD General
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
CN-MF-000033668
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from Sino-Swed TongKang Bio-Tech (Shenzhen) Limited.

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No