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gb HEMO FII (G20210A)

by GENERI BIOTECH s.r.o. EUDAMED

Active European Union

Ref 3201-100

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number85952239000008XA Basic UDI-DIDate16 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  • Withdrawn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

Model / Reference
3201-100
Primary DI / UDI-DI
08595223920133
Basic UDI-DI
85952239000008XA
EMDN Code
W0106010114 Prothrombin mutation
Device Class
Class C
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000018857

From the manufacturer

Manufacturer's product page: HEMO FII kit

Other devices from GENERI BIOTECH s.r.o.

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

Properties

Show properties
  • 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