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TiraSpot

by Spotlab Sl EUDAMED

Active European Union

Ref SPL-0002

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ESMF000044194TRS4W Basic UDI-DIDate3 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
TiraSpot
Model / Reference
SPL-0002
Primary DI / UDI-DI
D-ESMF000044194TRS4W
Basic UDI-DI
B-ESMF000044194TRS4W
EMDN Code
W02079092 Various general purpose IVD instruments - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000044194

Other devices from Spotlab Sl

Properties

  • Near-Patient Testing
  • Surgical Instrument

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No