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RNXtract® Automated Purification System

by Shuwen Biotech Co., Ltd. China EUDAMED

Ref SWP13Model NAP-T8

EMDN W02060199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697539401SWP13SA Basic UDI-DIDate20 Apr 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
NAP-T8, SWP13
Primary DI / UDI-DI
06975394010024
Basic UDI-DI
697539401SWP13SA
Direct Marketing DI
06975394010024
EMDN Code
W02060199 Robotic sample processing systems - 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
  • 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 4e3a75f4-e1ad-4e81-a7c1-c68d6b8781c5 61 fields · synced 22 Oct 2026