Skip to content

BlueNight Trainer

by Sleepinnov Technology France EUDAMED

Ref 1010001001

EMDN Z12159092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03770026864036 Basic UDI-DIDate29 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
1010001001
Primary DI / UDI-DI
03770026864036
Basic UDI-DI
B-03770026864036
EMDN Code
Z12159092 Various pneumology and respiratory physiopathology instruments - medical device software
Device Class
Class IIa
Special Device Type
-1192
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 (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 5978001b-7f06-423f-b981-670616ed4f87 61 fields · synced 22 Oct 2026