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Strep A Rapid Test

by VivaChek Biotech (Hangzhou) Co., Ltd. China EUDAMED

Ref GISTA-702H(1T/Kit)Model GISTA EMDN W0102039013

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976202760469 Basic UDI-DIDate30 Sep 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  • Withdrawn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

Model / Reference
GISTA, GISTA-702H(1T/Kit)
Primary DI / UDI-DI
06976202760469
Basic UDI-DI
B-06976202760469
EMDN Code
W0102039013 Fecal occult blood (ic)
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000012160
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from VivaChek Biotech (Hangzhou) Co., Ltd.

See all devices from VivaChek Biotech (Hangzhou) 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 (1)

  • EUDAMED 06976202760469|B-06976202760469 61 fields · synced 24 Oct 2026