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by HangZhou Biotest Biotech Co., Ltd. China EUDAMED

Ref ISTA-S81N002Model Cassette, strip

EMDN W0105090103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69340780STA81A00WK Basic UDI-DIDate21 Aug 2026RegisteredStatusActive

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

Device Name
Strep A Rapid Test Cassette(Throat Swab); Strep A Rapid Test Strip(Throat Swab)
Model / Reference
Cassette, strip, ISTA-S81N002
Primary DI / UDI-DI
06934078000362
Basic UDI-DI
69340780STA81A00WK
EMDN Code
W0105090103 Strep. a - rt & poc
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000008191
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from HangZhou Biotest Biotech Co., Ltd.

See all devices from HangZhou Biotest Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06934078000362|69340780STA81A00WK 61 fields · synced 23 Oct 2026