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Hi-bebe

by Bistos Co., Ltd. EUDAMED

Active European Union

Ref BT-200T

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800012320033 Basic UDI-DIDate21 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Ultrasound Doppler system with Probes
Model / Reference
BT-200T
Primary DI / UDI-DI
08800012320033
Basic UDI-DI
B-08800012320033
EMDN Code
Z12080103 Foetal heartbeat detectors
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000035951
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Bistos Co., Ltd.

See all devices from Bistos Co., Ltd. →

Properties

Show properties
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No