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Clinistix URI-2 Urinary Tract Infection Test Strips

by Siemens Healthcare Diagnostics Inc.

Ref 11834650Model IVDR_69_TTN_DUB-C_C_SELF_REAG_MICR_De-Centralized Urin Stat

Active European Union

CE IVDR

Valid until

25 Jun 2028

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901973WJ Basic UDI-DI 00630414659886UDI-DIDate24 Aug 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
IVDR_69_TTN_DUB-C_C_SELF_REAG_MICR_De-Centralized Urin Stat
Model / Reference
IVDR_69_TTN_DUB-C_C_SELF_REAG_MICR_De-Centralized Urin Stat, 11834650
Primary DI / UDI-DI
00630414659886
Basic UDI-DI
0405686901973WJ
Unit of Use DI
00630414324463
EMDN Code
W0101060204 Urine multi-constituent test strips (manual)
Device Class
Class C
EU 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
  • Self Testing
  • Near-Patient Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No