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RL348EX Starter Kit + Cl ROW

by Siemens Healthcare Diagnostics Inc. United States EUDAMED

Ref 10844683Model IVDR_69_TTN_DUB-C_C_NPT_REAG_BG-348EX

EMDN W0101060605

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901946WF Basic UDI-DIDate26 May 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_npt_reag_bg-348EX
Model / Reference
IVDR_69_TTN_DUB-C_C_NPT_REAG_BG-348EX, 10844683
Primary DI / UDI-DI
00630414947488
Basic UDI-DI
0405686901946WF
EMDN Code
W0101060605 Bg &/or ise &/or metabolites - electrodes (bg)
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

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Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 00630414947488|0405686901946WF 61 fields · synced 24 Oct 2026