Skip to content

RNXtract® Nucleic Acid Extraction Kit

by Shuwen Biotech Co., Ltd. China EUDAMED

Ref SWP10Model 48 tests/ ki EMDN W010699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697539401SWP10S4 Basic UDI-DIDate19 Apr 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
48 tests/ ki, SWP10
Primary DI / UDI-DI
06975394010017
Basic UDI-DI
697539401SWP10S4
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000034318
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Shuwen Biotech 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 3673b9b3-070c-4285-a421-6fc83d804304 61 fields · synced 22 Oct 2026