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Ura Premio - Clinical Chemistry Analyzer

by Medsource Ozone Biomedicals Private Limited

Ref EC9005

Withdrawn Withdrawn in European Union.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

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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-MOBPLEC9005PD Basic UDI-DI D-MOBPLEC9005PDUDI-DIDate4 Jun 2024RegisteredStatusWithdrawn 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  • Withdrawn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European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Device Name
Clinical Chemistry Analyzer
Model / Reference
EC9005
Primary DI / UDI-DI
D-MOBPLEC9005PD
Basic UDI-DI
B-MOBPLEC9005PD
EMDN Code
W02010199 Chemistry instruments - other
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
IN-MF-000042128
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties

  • 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
  • Professional Testing: No
  • Companion Diagnostics: No