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CYP2D6*10\CYP2C9*3\ADRB1(1165G>C)\AGTR1(1166A>C)\ACE(I/D) Detection Kit (PCR-Melting Curve Method)

by Wuxi Ruiqi Gene Biotechnology Co., Ltd.

Ref P157H, P129H

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974870710205 Basic UDI-DI Date26 Sep 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
CYP2D6*10\CYP2C9*3\ADRB1(1165G>C)\AGTR1(1166A>C)\ACE(I/D) Detection Kit (PCR-Melting Curve Method)
Model / Reference
P157H, P129H
Primary DI / UDI-DI
06974870710205, 06974870710199
Basic UDI-DI
B-06974870710205, B-06974870710199
EMDN Code
W0106010205 Hypertension
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

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

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Properties

  • 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