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CLINITEK Novus PRO 12 Urinalysis Cassette

by Siemens Healthcare Diagnostics Inc. EUDAMED

Active European Union

Ref 10634644Model IVDR_69_TTN_DUB-C_B_REAG_PROT_MICR_Centralized Urin Novus

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901966WM Basic UDI-DIDate9 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
IVDR_69_TTN_DUB-C_B_REAG_PROT_MICR_Centralized Urin Novus
Model / Reference
IVDR_69_TTN_DUB-C_B_REAG_PROT_MICR_Centralized Urin Novus, 10634644
Primary DI / UDI-DI
00630414602660
Basic UDI-DI
0405686901966WM
EMDN Code
W020101020185 Automated urine analysers - consumables
Device Class
Class B
Market of Registration
Germany

Manufacturer details

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

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No