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AdaptaSpot Smart

by Spotlab Sl EUDAMED

Active European Union

Ref SPL-0001Model 1.0

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ESMF000044194ADSYJ Basic UDI-DIDate12 Sep 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
1.0, SPL-0001
Primary DI / UDI-DI
D-ESMF000044194ADSYJ
Basic UDI-DI
B-ESMF000044194ADSYJ
EMDN Code
W02020199 Cell counting instruments - other
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

Show properties
  • 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
  • Professional Testing: No
  • Companion Diagnostics: No