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Rotavirus/Adenovirus Combo Rapid Test

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

Active European Union

Ref RAC-622a

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-RAC-622a8D Basic UDI-DIDate19 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  • Withdrawn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
Rotavirus/Adenovirus Combo Rapid Test
Model / Reference
RAC-622a
Primary DI / UDI-DI
D-RAC-622a8D
Basic UDI-DI
B-RAC-622a8D
EMDN Code
W0105090699 Other multiple pathogens - rt & poc
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.

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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