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Albustix

by Siemens Healthcare Diagnostics Inc. United States EUDAMED

Ref 10317384Model IVDR_69_TTN_DUB-C_C_SELF_REAG_MICR_De-Centralized Urin Stat

EMDN W0101060201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901973WJ Basic UDI-DIDate24 Aug 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_C_SELF_REAG_MICR_De-Centralized Urin Stat
Model / Reference
IVDR_69_TTN_DUB-C_C_SELF_REAG_MICR_De-Centralized Urin Stat, 10317384
Primary DI / UDI-DI
00630414984971
Basic UDI-DI
0405686901973WJ
Unit of Use DI
00630414306537
EMDN Code
W0101060201 Urine single test strips (incl. tablets)
Device Class
Class C
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 Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 00630414984971|0405686901973WJ 61 fields · synced 24 Oct 2026