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Human MTHFR\MTRR Gene Polymorphism Detection Kit (PCR-Melting Curve Method)

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

Ref P165H, P164H

EMDN W0106010299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974870710182 Basic UDI-DIDate26 Sep 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Human MTHFR\MTRR Gene Polymorphism Detection Kit (PCR-Melting Curve Method)
Model / Reference
P165H, P164H
Primary DI / UDI-DI
06974870710182, 06974870710175
Basic UDI-DI
B-06974870710182, B-06974870710175
EMDN Code
W0106010299 Polygenetic disorders tests - other
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000027697
Authorised representative
Lotus NL B.V. NL-AR-000000121

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

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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 (2)

  • EUDAMED b3ac5933-59fc-42e6-9f1b-38b48a9d340e 61 fields · synced 22 Oct 2026
  • EUDAMED 06974870710175|B-06974870710175 61 fields · synced 17 May 2026