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Multistix 5

by Siemens Healthcare Diagnostics Inc. 2 variants

Ref 10318564Model IVDR_69_TTN_DUB-C_B_NPT_REAG_MICR_De-Centralized Urin Stat

Active European Union

CE IVDR

Valid until

5 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 Number0405686901963WF Basic UDI-DI 00630414984988UDI-DIDate27 May 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  • Withdrawn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_B_NPT_REAG_MICR_De-Centralized Urin Stat
Model / Reference
IVDR_69_TTN_DUB-C_B_NPT_REAG_MICR_De-Centralized Urin Stat, 10318564
Primary DI / UDI-DI
00630414984988
Basic UDI-DI
0405686901963WF
Unit of Use DI
00630414306711
EMDN Code
W0101060205 Urine multi-constituent test strips (automated)
Device Class
Class B
EU 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.

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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