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ATMOSphere

by Dedalus Italia SpA Italy EUDAMED

Ref ATMOSphere, ATMOSphere Hematology EMDN W02079092

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805572803ATMOSE9 Basic UDI-DIDate29 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
ATMOSphere
ATMOSphere Hematology
Model / Reference
ATMOSphere, ATMOSphere Hematology
Primary DI / UDI-DI
08055728030268, 08055728030275, 08055728031067, 08055728031050, 08055728030916
Basic UDI-DI
805572803ATMOSE9
Direct Marketing DI
08055728030268
08055728030275
08055728031067
08055728031050
08055728030916
EMDN Code
W02079092 Various general purpose IVD instruments - IVD medical device software
Device Class
Class A
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009127

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Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • 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
  • Surgical Instrument: No
  • New Device: No

Sources (5)

  • EUDAMED 6ade5b57-039d-48d5-9fbd-1619e08e7ac9 61 fields · synced 22 Oct 2026
  • EUDAMED 08055728030275|805572803ATMOSE9 61 fields · synced 18 May 2026
  • EUDAMED 08055728031067|805572803ATMOSE9 61 fields · synced 10 Jul 2026
  • EUDAMED 08055728031050|805572803ATMOSE9 61 fields · synced 16 Jul 2026
  • EUDAMED 08055728030916|805572803ATMOSE9 61 fields · synced 29 Jul 2026