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Zika IgG/IgM/NS1 Combo Rapid Test

by Zhejiang Greylynx Biotech Co., Ltd. EUDAMED

Active European Union

Ref GIZGMN-432Model GIZGMN

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976202763378 Basic UDI-DIDate9 Jun 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  • Withdrawn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

Model / Reference
GIZGMN, GIZGMN-432
Primary DI / UDI-DI
06976202763378
Basic UDI-DI
B-06976202763378
EMDN Code
W0105040630 Zika virus
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.

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Properties

  • 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