Identity
- Trade Name
- Hi-bebe EUDAMEDHi-bebe S EUDAMED
- Device Name
- Ultrasound Doppler system with Probes EUDAMED
- Model / Reference
- BT-200L EUDAMEDBT-200T EUDAMEDBT-220C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800012320002 EUDAMED08800012320033 EUDAMED08800012322013 EUDAMED
- Basic UDI-DI
- B-08800012320002 EUDAMEDB-08800012320033 EUDAMEDB-08800012322013 EUDAMED
- EMDN Code
- Z12080103 FOETAL HEARTBEAT DETECTORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hi-bebe by Bistos Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800012320002 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bistos Co., Ltd.
- EUDAMED SRN
- KR-MF-000035951
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 49439fb0-589f-4207-9022-3ef4ff175df1 61 fields · synced Jul 29, 2026
- EUDAMED 1cb20634-dc27-4572-a5eb-a005ef64f92d 61 fields · synced May 17, 2026
- EUDAMED 10220d9b-6008-440c-9df8-4a0458f90f0e 61 fields · synced May 18, 2026