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Dimension Mycophenolic Acid Flex reagent cartridge

by Siemens Healthcare Diagnostics Inc. EUDAMED

Active European Union

Ref 10464329Model IVDR_67_GLA_DUB-C_C_REAG_MPAT

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901282VG Basic UDI-DIDate8 Sep 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  • Withdrawn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_GLA_DUB-C_c_reag_mpat
Model / Reference
IVDR_67_GLA_DUB-C_C_REAG_MPAT, 10464329
Primary DI / UDI-DI
00842768005329
Basic UDI-DI
0405686901282VG
EMDN Code
W0102080605 Mycophenolate
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000016336
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

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Properties

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