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Coagulation Analyzer

by Genrui Biotech Inc. 3 variants

Ref CA52Model CA51, CA52, CA54

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69503348CAA0019W Basic UDI-DI 06950334802020UDI-DIDate10 Apr 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
CA51, CA52, CA54
Primary DI / UDI-DI
06950334802020
Basic UDI-DI
69503348CAA0019W
EMDN Code
W0202020101 Semi-automated coagulometers
Device Class
Class A
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000017351
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Genrui Biotech Inc.

See all devices from Genrui Biotech Inc. →

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

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