Skip to content

FMR1 Cgg Pcr

by Beijing Healthgene Laboratory Co., Ltd China EUDAMED

Ref 50 Tests/Kit EMDN W0106010104

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00106010104013V8 Basic UDI-DIDate10 May 2023RegisteredStatusActive

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  • Withdrawn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 · synced 24 Oct 2026

Device Name
FMR1 Cgg Pcr
Model / Reference
50 Tests/Kit
Primary DI / UDI-DI
D-00106010104013V8
Basic UDI-DI
B-00106010104013V8
EMDN Code
W0106010104 Fragile x syndrome
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000032465
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Beijing Healthgene Laboratory Co., Ltd

Properties & raw data

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

Sources (1)

  • EUDAMED 2c27d035-0cf5-4dcb-aae6-17999ff85f09 61 fields · synced 24 Oct 2026