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SENTiFIT® 800 Analyzer

by SENTINEL CH. S.p.A. Italy EUDAMED

Ref 550802

EMDN W0201010299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805805668CIS80003I1226ANV Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
550802
Primary DI / UDI-DI
08058056684806
Basic UDI-DI
805805668CIS80003I1226ANV
Direct Marketing DI
08058056684806
EMDN Code
W0201010299 Limited panel chemistry analysers - other
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000012556

Other devices from SENTINEL CH. S.p.A.

See all devices from SENTINEL CH. S.p.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • 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
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 47c05bbe-1ae9-4237-9fb6-efa882f6d0a6 61 fields · synced 22 Oct 2026