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Rotavirus Test

by Zhejiang Greylynx Biotech Co., Ltd. EUDAMED

Active European Union

Ref GIROTA-602Model GIROTA

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976202762814 Basic UDI-DIDate26 May 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  • Withdrawn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 Rapid Test
Model / Reference
GIROTA, GIROTA-602
Primary DI / UDI-DI
06976202762814
Basic UDI-DI
B-06976202762814
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000032462
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zhejiang Greylynx Biotech Co., Ltd.

See all devices from Zhejiang Greylynx Biotech Co., Ltd. →

Properties

  • 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