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PMA.core

by Pathomation BV Belgium EUDAMED

Ref PMA.core 3.0

EMDN Z11069092

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-54199804460PMAcore34C59 Basic UDI-DIDate20 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
PMA.core 3.0
Model / Reference
PMA.core 3.0
Primary DI / UDI-DI
D-54199804460PMAcore34C59
Basic UDI-DI
B-54199804460PMAcore34C59
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000035661

From the manufacturer

Manufacturer's product page: The PMA.core Technology

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 82597869-c679-4f3f-aa12-6150d2462f64 61 fields · synced 22 Oct 2026