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Lys-3

by Spinreact S.A.U.

Ref 1705110Model No

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number8431673HETF03T7 Basic UDI-DI 08431673720292UDI-DIDate12 Jun 2026RegisteredStatusActive
European UnionCE/IVDR Number8431673HETF03T7 Basic UDI-DI 08431673720292UDI-DIDate12 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Device Name
Lyse reagent Spincell 3 series
Model / Reference
1705110, No
Primary DI / UDI-DI
08431673720292
Basic UDI-DI
8431673HETF03T7, B-08431673720292
Direct Marketing DI
08431673720292
EMDN Code
W0103010105, W0202010285
Device Class
Class A
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000011023

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Properties

  • 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