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Shea-5

by Spinreact S.A.U. Spain EUDAMED

Ref 1705681Model No

EMDN W0103010105

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number8431673HETF08TH Basic UDI-DIDate30 Apr 2026RegisteredStatusActive
European UnionCE/IVDR Number8431673HETF08TH 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 25 Oct 2026

Device Name
Sheat reagent Spincell 5 series
Sheath reagent Spincell 5 Series
Model / Reference
1705681, No
Primary DI / UDI-DI
08431673755850
Basic UDI-DI
8431673HETF08TH, B-08431673755850
Direct Marketing DI
08431673755850
EMDN Code
W0103010105, W0202010185
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
  • 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 6ef94b6a-089f-4efa-b2ee-7da4daf73360 61 fields · synced 23 Oct 2026
  • EUDAMED 08431673755850|B-08431673755850 61 fields · synced 25 Oct 2026