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Rotavirus Rapid Test Cassette

by Hangzhou Alltest Biotech.Co., Ltd. EUDAMED

Active European Union

Ref IRO-602

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-IRO-602WK Basic UDI-DIDate20 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Trade Name
Rotavirus Rapid Test Cassette
Rotavirus Rapid Test Cassette(Feces)
Model / Reference
IRO-602
Primary DI / UDI-DI
D-IRO-602WK, 06936983118934
Basic UDI-DI
B-IRO-602WK, B-06936983118934
EMDN Code
W0105040606, W0105099099
Device Class
Class IVD General
Market of Registration
Austria
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000010710
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Hangzhou Alltest Biotech.Co., Ltd.

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Properties

  • Animal Tissues
  • Reagent NoEUDAMEDYesEUDAMED
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No