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Respi.Me

by Voluntis France EUDAMED

Ref 3.12

EMDN Z12040282

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376026131RESP002CT Basic UDI-DIDate19 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
3.12
Primary DI / UDI-DI
03760261310207, 03760261310191
Basic UDI-DI
376026131RESP002CT
Direct Marketing DI
03760261310207
03760261310191
EMDN Code
Z12040282 General medicine therapeutic treatment instruments - software accessories
Device Class
Class I
Special Device Type
Software
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000003043

Other devices from Voluntis Sa.

See all devices from Voluntis Sa. →

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 (2)

  • EUDAMED 021149f3-3813-477d-9de1-101c9096ff08 61 fields · synced 23 Oct 2026
  • EUDAMED 03760261310191|376026131RESP002CT 61 fields · synced 19 May 2026