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Aolun Clini-Lab80Pro

by Chongqing Aolun Technology Co., Ltd.

Ref 10081Model Clini-Lab80Pro，Clini-Lab100Pro，3 Clini-Lab500Pro

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDR, withdrawn

Ended

Withdrawn

Date not published (CE IVDR)

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 Number697829101W0201010201VF Basic UDI-DI 06978291020011UDI-DIDate25 May 2026RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/IVDR Withdrawn

Specification

EUDAMED

Device Name
Urine Analyzer
Model / Reference
Clini-Lab80Pro，Clini-Lab100Pro，3 Clini-Lab500Pro, 10081
Primary DI / UDI-DI
06978291020011
Basic UDI-DI
697829101W0201010201VF
EMDN Code
W020101020101 Urine strip readers
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000046602
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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