Skip to content

Disposable Sample Kit

by Wuxi NEST Biotechnology Co., Ltd China EUDAMED

Ref 202115

EMDN W05019099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697312286samplekitN6 Basic UDI-DIDate21 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Disposable Sample Kit
Model / Reference
202115
Primary DI / UDI-DI
06941854800801
Basic UDI-DI
697312286samplekitN6
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000002299
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wuxi Nest Biotechnology Co., Ltd.

See all devices from Wuxi Nest Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 48da8b27-889d-490d-857e-9108e0daa793 61 fields · synced 23 Oct 2026