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Babysense

by Hisense Ltd. Israel EUDAMED

Ref CU-100/2-E

EMDN Z12080406

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07290004018627 Basic UDI-DIDate11 Nov 2025RegisteredStatusActive

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

Device Name
Babysense 7
Babysense 8
Model / Reference
CU-100/2-E
Primary DI / UDI-DI
07290004018627, 07290119471249
Basic UDI-DI
B-07290004018627, B-07290119471249
EMDN Code
Z12080406 Apnoea monitors
Device Class
Class IIb
Market of Registration
Poland
Germany

Manufacturer details

EUDAMED SRN
IL-MF-000034666
Authorised representative
Obelis s.a. BE-AR-000000106

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 (2)

  • EUDAMED 2cee5ae8-eecb-40df-b2b5-09a33c4aa8ce 61 fields · synced 22 Oct 2026
  • EUDAMED 07290119471249|B-07290119471249 61 fields · synced 19 May 2026