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PredicineCARE Assay

by Predicine, Inc. United States EUDAMED

Ref PD-CA9999KEModel PredicineCARE DeepSEA 1.7.3 EMDN W01060299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08600139976PDCA9999KER6 Basic UDI-DIDate20 May 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  • Withdrawn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
PredicineCARE™ Assay
Model / Reference
PredicineCARE DeepSEA 1.7.3, PD-CA9999KE
Primary DI / UDI-DI
00860013997625
Basic UDI-DI
08600139976PDCA9999KER6
Direct Marketing DI
00860013997625
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class C
Special Device Type
Software
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000031888
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Predicine, Inc.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • New Device
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 7c620f1d-7888-427d-9304-e341cfb6af8a 61 fields · synced 25 Oct 2026