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Biochemistry analyzer

by Clindiag Systems Co., Ltd

Ref CH-12Model CH-12，CH-24 FA-160，FA-200，FA-300，FA-400，FA-600，FA-800 SA-20，SA-30，SA-30A，SA-30C

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 Number697815103KLDBAJT Basic UDI-DI 06978151030006UDI-DIDate30 Dec 2024RegisteredStatusActive

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  • Withdrawn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

Device Name
Biochemistry analyzer
Model / Reference
CH-12，CH-24 FA-160，FA-200，FA-300，FA-400，FA-600，FA-800 SA-20，SA-30，SA-30A，SA-30C, CH-12
Primary DI / UDI-DI
06978151030006
Basic UDI-DI
697815103KLDBAJT
EMDN Code
W02010199 Chemistry instruments - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000043506
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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