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General Chemistry III Kit (Microfluidic Dry Chemistry)

by Chengdu Polytech Biological Technology Co., Ltd. 11 variants

Ref AW00430Model 10 Liver Function Kit

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975429090304 Basic UDI-DI 06975429090304UDI-DIDate20 Jul 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
10 Liver Function Kit, AW00430
Primary DI / UDI-DI
06975429090304
Basic UDI-DI
B-06975429090304
EMDN Code
W01010404 Multiple parameters (mix of all) - clin. chem lab r.
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000034373
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Chengdu Polytech Biological Technology Co., Ltd.

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Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Surgical Instrument: No