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Pentagramma

by Dedalus Italia SpA Italy EUDAMED

Ref PENTAGRAMMAModel Pentagramma

EMDN W02079092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805572803PENTAGRAMMAA9 Basic UDI-DIDate29 Dec 2025RegisteredStatusActive

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
Pentagramma
Primary DI / UDI-DI
08055728030213, 08055728030459, 08055728030602, 08055728030312
Basic UDI-DI
805572803PENTAGRAMMAA9
Direct Marketing DI
08055728030213
08055728030459
08055728030602
08055728030312
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 (4)

  • EUDAMED 2a5d0db6-8262-4999-9805-63e91c284715 61 fields · synced 22 Oct 2026
  • EUDAMED 08055728030459|805572803PENTAGRAMMAA9 61 fields · synced 18 Jun 2026
  • EUDAMED 08055728030602|805572803PENTAGRAMMAA9 61 fields · synced 18 Jun 2026
  • EUDAMED 08055728030312|805572803PENTAGRAMMAA9 61 fields · synced 21 Jul 2026