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Labstix

by Siemens Healthcare Diagnostics Inc. EUDAMED

Active European Union

Ref 10327901Model IVDR_69_TTN_DUB-C_B_NPT_REAG_MICR_De-Centralized Urin Stat

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901963WF Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Device Name
IVDR_69_TTN_DUB-C_B_NPT_REAG_MICR_De-Centralized Urin Stat
Model / Reference
IVDR_69_TTN_DUB-C_B_NPT_REAG_MICR_De-Centralized Urin Stat, 10327901
Primary DI / UDI-DI
00630414985077
Basic UDI-DI
0405686901963WF
Unit of Use DI
00630414306780
EMDN Code
W0101060204 Urine multi-constituent test strips (manual)
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

Other devices from Siemens Healthcare Diagnostics

See all devices from Siemens Healthcare Diagnostics →

Properties

  • Microbial Substances
  • Reagent
  • Near-Patient Testing

Other properties (8)

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