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gb GENETIC APOB (R3500Q)

by GENERI BIOTECH s.r.o. Czechia EUDAMED

Ref 3205-025 EMDN W0106010203

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number85952239000002WW Basic UDI-DIDate13 Oct 2023RegisteredStatusActive

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  • Withdrawn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
3205-025
Primary DI / UDI-DI
08595223920515
Basic UDI-DI
85952239000002WW
EMDN Code
W0106010203 Atherosclerosis
Device Class
Class C
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000018857

From the manufacturer

Manufacturer's product page: gb GENETIC APOB (R3500Q)

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 08595223920515|85952239000002WW 61 fields · synced 24 Oct 2026