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Id Hpa Xt

by Progenika Biopharma, S.A. Spain EUDAMED

Ref 1010220034 EMDN W02050192

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8437013457Gentest003QP Basic UDI-DIDate4 Jul 2025RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Trade Name
Id Hpa Xt
ID HPA XT Reagents
Device Name
Id Hpa Xt Analysis Software
Model / Reference
1010220034
Primary DI / UDI-DI
08437013457699, 08437013457279
Basic UDI-DI
8437013457Gentest003QP, 8437013457Gentest002QM
Direct Marketing DI
08437013457699
08437013457279
EMDN Code
W02050192, W0106010499
Device Class
Class C
Special Device Type
Software
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
  • Reagent NoEUDAMEDYesEUDAMED
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED c100fdf3-fedf-409c-b86c-c39ddcb57f23 61 fields · synced 22 Oct 2026
  • EUDAMED 08437013457279|8437013457GENTEST002QM 61 fields · synced 19 May 2026