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Genedian

by Hangzhou DIAN Biotechnology Co., Ltd. China EUDAMED

Ref P114-00004Model iRapid 4

EMDN W02050301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69342445IA002FK Basic UDI-DIDate3 Nov 2022RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
iRapid4 POC RT-PCR Detection System
Model / Reference
iRapid 4, P114-00004
Primary DI / UDI-DI
06934244500139
Basic UDI-DI
69342445IA002FK
EMDN Code
W02050301 Nucleic acid testing apparatuses - rapid and point of care tests
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000007252
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Hangzhou DIAN Biotechnology Co., Ltd.

See all devices from Hangzhou DIAN Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED ac8824bc-37cc-4e33-b05e-3df9a0e63407 61 fields · synced 24 Oct 2026