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CLINITEK Status+ Analyzer

by Siemens Healthcare Diagnostics Inc. EUDAMED

Active European Union

Ref 10379680Model IVDR_69_TTN_DUB-C_A_NPT_INST_De-Centralized Urin Stat

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901945WD Basic UDI-DIDate12 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
IVDR_69_TTN_DUB-C_A_NPT_INST_De-Centralized Urin Stat
Model / Reference
IVDR_69_TTN_DUB-C_A_NPT_INST_De-Centralized Urin Stat, 10379680
Primary DI / UDI-DI
00630414572345
Basic UDI-DI
0405686901945WD
EMDN Code
W020101020103 Automated urine analysers
Device Class
Class A
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000016560
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

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Properties

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No