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Lys-5

by Spinreact S.A.U. Spain EUDAMED

Ref 1705610Model No

EMDN W0202010185

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08431673755843 Basic UDI-DIDate29 Jul 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-08431673755843 Basic UDI-DIDate29 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Lyse reagent Spincell 5 Series
Lyse reagent Spincell 5 series
Model / Reference
No, 1705610
Primary DI / UDI-DI
08431673755843
Basic UDI-DI
B-08431673755843, 8431673HETF07TF
Direct Marketing DI
08431673755843
EMDN Code
W0202010185, W0103010105
Device Class
Class IVD General
Class A
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
  • 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 (2)

  • EUDAMED 08431673755843|B-08431673755843 61 fields · synced 25 Oct 2026
  • EUDAMED 08431673755843|8431673HETF07TF 61 fields · synced 25 Oct 2026