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Ovulation and Pregnancy Test Combi Pack

by Sanavita Pharmaceuticals GmbH Germany EUDAMED

Ref COMBIPACK

EMDN W0102160399

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-COMBIPACKLB Basic UDI-DIDate3 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Ovulation and Pregnancy Test Combi Pack
Model / Reference
COMBIPACK
Primary DI / UDI-DI
D-COMBIPACKLB
Basic UDI-DI
B-COMBIPACKLB
EMDN Code
W0102160399 Fertility/pregnancy rt & poc - other
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005463

Other devices from Sanavita Pharmaceuticals GmbH

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Self Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 0123472a-4d89-428c-9c14-00f9cea5f655 61 fields · synced 22 Oct 2026