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Tholomeus

by Biotechmed S.r.l. Italy EUDAMED

Ref Version 2.6.0Model Version 2

EMDN Z12039092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805969359THOLOMEUSJ7 Basic UDI-DIDate12 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Version 2, Version 2.6.0
Primary DI / UDI-DI
08059693592608
Basic UDI-DI
805969359THOLOMEUSJ7
Direct Marketing DI
08059693592608
EMDN Code
Z12039092 Various instruments to support and monitor vital signs - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000030231

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED db3b059f-1fa8-4257-9fda-4f852e01a21b 61 fields · synced 24 Oct 2026