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Haloa

by Sleepinnov Technology France EUDAMED

Ref 6100001001

EMDN Z12030102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-03770026864005 Basic UDI-DIDate29 Apr 2022RegisteredStatusActive
European UnionCE/MDD NumberB-03770026864005 Basic UDI-DIDate29 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
6100001001
Primary DI / UDI-DI
03770026864005
Basic UDI-DI
B-03770026864005, 37700268646100001001FQ
Direct Marketing DI
03770026864005
EMDN Code
Z12030102 Continuous positive pressure equipment
Device Class
Class IIa
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 (2)

  • EUDAMED 9ee01215-e778-4f11-8677-c36331f8b3ef 61 fields · synced 22 Oct 2026
  • EUDAMED 03770026864005|37700268646100001001FQ 61 fields · synced 24 Oct 2026