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RAPIDPoint® 500e System Refurbish

by Siemens Healthcare Diagnostics Inc. United States EUDAMED

Ref 11555831Model IVDR_69_TTN_DUB-C_A_NPT_INST_BG-RapidPoint EMDN W0201040180

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901944WB Basic UDI-DIDate21 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
IVDR_69_TTN_DUB-C_A_NPT_INST_BG-RapidPoint
Model / Reference
IVDR_69_TTN_DUB-C_A_NPT_INST_BG-RapidPoint, 11555831
Primary DI / UDI-DI
00630414658759
Basic UDI-DI
0405686901944WB
EMDN Code
W0201040180 Blood gas analysers - hardware accessories
Device Class
Class A
Market of Registration
Belgium

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
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 00630414658759|0405686901944WB 61 fields · synced 25 Oct 2026