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β-hydroxybutyrate acid Assay kit (Enzyme Chemical Reaction Method)

by Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd.

Ref 20 tests/box

Active European Union

CE IVDD

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/IVDD NumberB-06975808410372 Basic UDI-DI 06975808410372UDI-DIDate24 Sep 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
β-hydroxybutyrate acid Assay kit (Enzyme Chemical Reaction Method)
Model / Reference
20 tests/box
Primary DI / UDI-DI
06975808410372
Basic UDI-DI
B-06975808410372
EMDN Code
W01010499 Multiple clin. chem lab reagents - other
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000044320
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd.

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No