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Chek-Stix Combo Pak

by Siemens Healthcare Diagnostics Inc. United States EUDAMED

Ref 10316287Model IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Chek

EMDN W0101060204

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901954WE Basic UDI-DIDate17 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 24 Oct 2026

Device Name
IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Chek
Model / Reference
IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Chek, 10316287
Primary DI / UDI-DI
00630414538426
Basic UDI-DI
0405686901954WE
Unit of Use DI
00630414323374
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

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Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 00630414538426|0405686901954WE 61 fields · synced 24 Oct 2026