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HAV IgM Rapid Test

by Medotex Biotech (HangZhou) Co., Ltd. China EUDAMED

Ref HAVM-402a EMDN W0105090299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-HAVM-402a6Q Basic UDI-DIDate19 Oct 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  • Withdrawn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 24 Oct 2026

Device Name
HAV IgM Rapid Test
Model / Reference
HAVM-402a
Primary DI / UDI-DI
D-HAVM-402a6Q
Basic UDI-DI
B-HAVM-402a6Q
EMDN Code
W0105090299 Hepatitis viruses - rt & poc - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000051631
Authorised representative
Llins Service & Consulting GmbH DE-AR-000009077

Other devices from Medotex Biotech (HangZhou) Co., Ltd.

See all devices from Medotex Biotech (HangZhou) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-HAVM-402A6Q|B-HAVM-402A6Q 61 fields · synced 24 Oct 2026