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SERATEC Deluxe Frühtest

by SERATEC Gesellschaft für Biotechnologie mbH Germany EUDAMED

Ref HCG-M2 EMDN W0102050205

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-De-MF-000031456KY Basic UDI-DIDate13 May 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
HCG-M2
Primary DI / UDI-DI
D-De-MF-000031456KY
Basic UDI-DI
B-De-MF-000031456KY
EMDN Code
W0102050205 Total human chorionic gonadotropin
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000031456

Other devices from SERATEC Gesellschaft für Biotechnologie mbH

Properties & raw data

Show properties, registry sources and raw records
  • Self Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 3e7d2351-686f-4a38-8c52-0e32f4baf6df 61 fields · synced 22 Oct 2026