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Fully Automated Fecal Immunochemical Test Analyzer

by Shenzhen Cavan Biotech Co., Ltd. 4 variants

Ref FIT-1600Model FIT-1000/1200/1600/1800

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 Number697756820FIT-EQSV Basic UDI-DI 06977568200170UDI-DIDate6 May 2026RegisteredStatusActive

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  • Withdrawn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
FIT-1000/1200/1600/1800, FIT-1600
Primary DI / UDI-DI
06977568200170
Basic UDI-DI
697756820FIT-EQSV
EMDN Code
W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000052933
Authorised representative
HyperCert Limited B.V. NL-AR-000047746

Other devices from Shenzhen Cavan Biotech Co., Ltd.

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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