Skip to content

Chek-Stix Combo Pak

by Siemens Healthcare Diagnostics Inc. 2 variants

Ref 10325654Model IVDR_69_TTN_DUB-C_B_NPT_REAG_De-Centralized Urin Chek

Expiring European Union

CE IVDR

Valid until

17 Aug 2027

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901954WE Basic UDI-DI 00630414538419UDI-DIDate17 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IX 1290554-18 Expiring Expires in 287 days

    Technical documentation EU IVDR

    Certifier
    TÜV Rheinland LGA Products GmbH 0197
    Issued
    18 Aug 2022
    Expires
    17 Aug 2027

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Expiring

Specification

EUDAMED

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, 10325654
Primary DI / UDI-DI
00630414538419
Basic UDI-DI
0405686901954WE
Unit of Use DI
00630414306650
EMDN Code
W010106020601 Urine testing controls
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.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • 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