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Norovirus Antigen Rapid Test

by Medotex Biotech (HangZhou) Co., Ltd. EUDAMED

Active European Union

Ref NORO-622a

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-NORO-622aJS Basic UDI-DIDate15 Oct 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  • Withdrawn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

Device Name
Norovirus Antigen Rapid Test
Model / Reference
NORO-622a
Primary DI / UDI-DI
D-NORO-622aJS
Basic UDI-DI
B-NORO-622aJS
EMDN Code
W0105040616 Norovirus
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000051631
Authorised representative
Llins Service & Consulting GmbH DE-AR-000009077

Other devices from Medotex Biotech (HangZhou) Co., Ltd.

See all devices from Medotex Biotech (HangZhou) Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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