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Genedian

by Hangzhou DIAN Biotechnology Co., Ltd. China EUDAMED

Ref P131-04050

EMDN W05019099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69342445RA002JN Basic UDI-DIDate3 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Virus Collection and Preservation System
Model / Reference
P131-04050
Primary DI / UDI-DI
06934244540043
Basic UDI-DI
69342445RA002JN
EMDN Code
W05019099 Samples collection devices - other
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
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 74704336-10df-48a1-9fc4-5f595c3a20a8 61 fields · synced 22 Oct 2026