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Atellica IM total PSA II (tPSAII)

by Siemens Healthcare Diagnostics Inc. EUDAMED

Active European Union

Ref 11202246Model IVDR_67_TTN_DUB-C_C_REAG_KIT_hsPSA

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686902251VC Basic UDI-DIDate18 Jun 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  • Withdrawn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

Device Name
IVDR_67_TTN_DUB-C_C_REAG_KIT_hsPSA
Model / Reference
IVDR_67_TTN_DUB-C_C_REAG_KIT_hsPSA, 11202246
Primary DI / UDI-DI
00630414240138
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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