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AutoChem ISE Diluent

by Autobio Diagnostics Co., Ltd. China EUDAMED

Ref 360115SED0002Model AutoChem

EMDN W01019002

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69422530000131NE Basic UDI-DIDate26 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
AutoChem, 360115SED0002
Primary DI / UDI-DI
06942253020722
Basic UDI-DI
69422530000131NE
EMDN Code
W01019002 Electrophoresis media (unassignable)
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000003348
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Autobio Diagnostics Co., Ltd.

See all devices from Autobio Diagnostics Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06942253020722|69422530000131NE 61 fields · synced 24 Oct 2026