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Pregnancy (hCG) Test

by Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş. EUDAMED 20 variants

Active European Union

Ref THCG03

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08693285185894 Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Pregnancy (hCG) Test
Model / Reference
THCG03
Primary DI / UDI-DI
08693285185894
Basic UDI-DI
B-08693285185894
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000028553

From the manufacturer

Manufacturer's product page: hCG Gebelik Kaset TESTİ

Other devices from Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.

See all devices from Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş. →

Properties

  • Animal Tissues
  • Professional Testing

Other properties (8)

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