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Automatic Chemiluminescence Immunoassay Analyzer

by Virtue Diagnostics (Suzhou) Co., Ltd

Ref 11000002, 11000003Model VERCENTRA CS-1500, VERCENTRA CS-3000

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697440255INST_VIRTUOSO6E Basic UDI-DI Date12 Mar 2023RegisteredStatusActive

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  • Withdrawn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
VERCENTRA CS-1500, VERCENTRA CS-3000, 11000002, 11000003
Primary DI / UDI-DI
06974402559012, 06974402559029
Basic UDI-DI
697440255INST_VIRTUOSO6E
Direct Marketing DI
06974402559012
06974402559029
EMDN Code
W0201020102, W0201020103
Device Class
Class A
EU market of registration
Netherlands
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000013251
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

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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