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Haloa BLE

by Sleepinnov Technology France EUDAMED

Ref 6100002009

EMDN Z1203019082

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37700268646100002009GF Basic UDI-DIDate18 May 2026RegisteredStatusActive

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
6100002009
Primary DI / UDI-DI
03770026864043
Basic UDI-DI
37700268646100002009GF
Direct Marketing DI
03770026864043
EMDN Code
Z1203019082 Various instruments for anaesthesia and pulmonary ventilation support - software accessories
Device Class
Class IIa
Special Device Type
Software
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000016061

Other devices from Sleepinnov Technology

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 03770026864043|37700268646100002009GF 61 fields · synced 24 Oct 2026