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gb ONCO JAK2 (V617F)

by GENERI BIOTECH s.r.o. Czech Republic EUDAMED

Ref 3286-024 EMDN W01060299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number85952239000038XK Basic UDI-DIDate7 Aug 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  • Withdrawn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 24 Oct 2026

Model / Reference
3286-024
Primary DI / UDI-DI
08595223928610
Basic UDI-DI
85952239000038XK
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class C
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000018857

Other devices from GENERI BIOTECH s.r.o.

See all devices from GENERI BIOTECH s.r.o. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 08595223928610|85952239000038XK 61 fields · synced 24 Oct 2026