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Spin Xs

by Spinreact S.A.U. Spain EUDAMED

Ref 5001009Model No

EMDN W0201010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number8431673INTF01WK Basic UDI-DIDate30 Apr 2026RegisteredStatusActive
European UnionCE/IVDR Number8431673INTF01WK Basic UDI-DIDate30 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Clinical chemistry analyzer
Clinical Chemistry Analyzer Fully Automated
Model / Reference
5001009, No
Primary DI / UDI-DI
08431673290542
Basic UDI-DI
8431673INTF01WK, B-08431673290542
Direct Marketing DI
08431673290542
EMDN Code
W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
Device Class
Class A
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000011023

Other devices from Spinreact S.A.U.

See all devices from Spinreact S.A.U. →

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 (2)

  • EUDAMED 6e56a2a5-4152-4a39-886d-408fb9000aa7 61 fields · synced 24 Oct 2026
  • EUDAMED 08431673290542|B-08431673290542 61 fields · synced 24 Oct 2026