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SARS-CoV-2 Ag Rapid Test

by Zhejiang Greylynx Biotech Co., Ltd. China EUDAMED

Ref GISARSg-702Model GISARSg EMDN W0105090501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976202763071 Basic UDI-DIDate4 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  • Withdrawn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 · synced 24 Oct 2026

Trade Name
SARS-CoV-2 Ag Rapid Test
SARS-CoV-2 Ag Saliva Rapid Test
Model / Reference
GISARSg, GISARSg-702
Primary DI / UDI-DI
06976202763071, 06976202763064
Basic UDI-DI
B-06976202763071, B-06976202763064
EMDN Code
W0105090501 Coronavirus antigen (ag) - rt & poc
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 ab66308b-a776-4bf3-a032-479477d6e78c 61 fields · synced 24 Oct 2026
  • EUDAMED 06976202763064|B-06976202763064 61 fields · synced 24 Oct 2026