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Promonitor-UTK

by Progenika Biopharma, S.A. Spain EUDAMED

Ref 5371530000

EMDN W0102080799

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8437013457Promonitor013GW Basic UDI-DIDate27 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
5371530000
Primary DI / UDI-DI
08437013457385
Basic UDI-DI
8437013457Promonitor013GW
Direct Marketing DI
08437013457385
EMDN Code
W0102080799 Autoimmune disease tdm - other
Device Class
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001005

Other devices from Progenika Biopharma, S.A.

See all devices from Progenika Biopharma, S.A. →

Properties & raw data

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

Sources (1)

  • EUDAMED d8c812c3-571d-4c25-b166-042cad7373ef 61 fields · synced 25 Oct 2026