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Automatic Chemiluminescence Immunoassay Analyzer

by Keylights Biotechnology (Chongqing) Co., Ltd. 2 variants

Ref BioCLIA 6900Model Venus 100S,Venus 120S,Venus 100H,Venus 120H,BioCLIA 1900,Venus 500,VERCENTRA CS-6000,BioCLIA 6900

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697587967KLS00019Q Basic UDI-DI 06975879670101UDI-DIDate20 Jun 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  • Withdrawn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
Venus 100S, Venus 120S, Venus 100H, Venus 120H, BioCLIA 1900, Venus 500, VERCENTRA CS-6000, BioCLIA 6900
Primary DI / UDI-DI
06975879670101
Basic UDI-DI
697587967KLS00019Q
EMDN Code
W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
Device Class
Class A
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000033853
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Keylights Biotechnology (Chongqing) Co., Ltd.

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