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Strep A Rapid Test

by Zhejiang Greylynx Biotech Co., Ltd. China EUDAMED

Ref GISTA-702H(2T/kit)Model GISTA-702H

EMDN W0105090103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697620276GISTA000014E Basic UDI-DIDate20 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
GISTA-702H, GISTA-702H(2T/kit)
Primary DI / UDI-DI
06976202760032
Basic UDI-DI
697620276GISTA000014E
EMDN Code
W0105090103 Strep. a - rt & poc
Device Class
Class C
Market of Registration
Poland

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
  • Self Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 5eaae82e-d8c3-48e6-be6e-cba44d20f27e 61 fields · synced 23 Oct 2026