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System ONE-M - IT

by TOOsonix A/S Denmark EUDAMED

Ref S02

EMDN V9099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57000021926SysONE-MRZ Basic UDI-DIDate10 Apr 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
System ONE-M
Model / Reference
S02
Primary DI / UDI-DI
05700002312709
Basic UDI-DI
57000021926SysONE-MRZ
Direct Marketing DI
05700002312709
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class IIa
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014211

Other devices from TOOsonix A/S

See all devices from TOOsonix A/S →

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 6caea6d3-e97d-41ae-9133-a47b858e62d9 61 fields · synced 22 Oct 2026