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Geratherm® early detect

by Geratherm Medical GERMANY GmbH Germany EUDAMED

Ref 9750000110 EMDN W0102160302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-4018674GTPST01ZBM4 Basic UDI-DIDate12 Jun 2023RegisteredStatusActive

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  • Withdrawn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
9750000110
Primary DI / UDI-DI
D-4018674GTPST01ZBM4
Basic UDI-DI
B-4018674GTPST01ZBM4
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000007307

From the manufacturer

Manufacturer's product page: early detect

Other devices from Geratherm Medical GERMANY GmbH

See all devices from Geratherm Medical GERMANY GmbH →

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 a3185b54-6f31-445a-90cb-f5d650cfe84e 61 fields · synced 22 Oct 2026