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Pregnancy (hCG) Test

by Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş. Türkiye EUDAMED

Ref RTHCG10 EMDN W0102160302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08693285182749 Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Pregnancy (hCG) Test
Model / Reference
RTHCG10
Primary DI / UDI-DI
08693285182749
Basic UDI-DI
B-08693285182749
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED fc3fce32-9fd7-4639-ac0a-ba6b2f7fe321 61 fields · synced 22 Oct 2026