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Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)

by PSI Gene Technology Co., Ltd. EUDAMED

Active European Union

Ref 12 tests/kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975843690012 Basic UDI-DIDate18 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)
Model / Reference
12 tests/kit
Primary DI / UDI-DI
06975843690012
Basic UDI-DI
B-06975843690012
EMDN Code
W0106010299 Polygenetic disorders tests - other
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000023276
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from PSI Gene Technology Co., Ltd.

Properties

Show properties
  • Sterile
  • Reagent
  • Professional Testing
Other properties (7)
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No