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TGS Human MTHFR (C677T) Gene Polymorphism Detection Kit

by Wuxi Ruiqi Gene Biotechnology Co., Ltd. China EUDAMED

Ref BM150028 EMDN W0106010199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974870710274 Basic UDI-DIDate1 Apr 2026RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
TGS Human MTHFR (C677T) Gene Polymorphism Detection Kit
Model / Reference
BM150028
Primary DI / UDI-DI
06974870710274
Basic UDI-DI
B-06974870710274
EMDN Code
W0106010199 Monogenetic disorders tests - other
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000027697
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wuxi Ruiqi Gene Biotechnology Co., Ltd.

See all devices from Wuxi Ruiqi Gene Biotechnology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED c8105690-2bd1-4bf0-9d90-0f24627cc6d4 61 fields · synced 22 Oct 2026