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Immunofluorescence Analyzer

by Guangdong Wesail Biotech Co., Ltd. China EUDAMED

Ref WS-Mi6000 EMDN W0201020103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697384100B600055 Basic UDI-DIDate28 Aug 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  • Withdrawn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 23 Oct 2026

Model / Reference
WS-Mi6000
Primary DI / UDI-DI
06973841000307
Basic UDI-DI
697384100B600055
Direct Marketing DI
06973841000307
EMDN Code
W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000008828
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Guangdong Wesail Biotech Co., Ltd.

See all devices from Guangdong Wesail 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 86761e5c-2370-4a33-8a83-8691585eabd8 61 fields · synced 23 Oct 2026