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HAV IgG/IgM Test

by Zhejiang Greylynx Biotech Co., Ltd. China EUDAMED

Ref GIHAVb-422Model GIHAVb

EMDN W0105020102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976202762616 Basic UDI-DIDate26 May 2026RegisteredStatusActive

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

Trade Name
HAV IgG/IgM Test
HAV IgG/IgM Rapid Test
Model / Reference
GIHAVb, GIHAVb-422
Primary DI / UDI-DI
06976202762616, 06976202762081
Basic UDI-DI
B-06976202762616, B-06976202762081
EMDN Code
W0105020102 Hav antibody (total)
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000032462
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zhejiang Greylynx Biotech Co., Ltd.

See all devices from Zhejiang Greylynx Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED 662eab72-b1a4-449d-b26f-855e45ea35f8 61 fields · synced 22 Oct 2026
  • EUDAMED 06976202762081|B-06976202762081 61 fields · synced 19 Jun 2026