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Creatinine, Microalbumin in Urine Assay kit (Dry Chemical Method)

by Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd.

Ref 1 test/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-06975808410198 Basic UDI-DI 06975808410198UDI-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  • Withdrawn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
Creatinine, Microalbumin in Urine Assay kit (Dry Chemical Method)
Model / Reference
1 test/box
Primary DI / UDI-DI
06975808410198
Basic UDI-DI
B-06975808410198
EMDN Code
W01010999 Multiple parameters urine testing - 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