Identity
- Device Name
- Ultrasound Doppler system with Probes EUDAMED
- Model / Reference
- BT-250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800012325007 EUDAMED
- Basic UDI-DI
- B-08800012325007 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
Ultrasound Doppler system with Probes 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-08800012325007 | 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 (1)
- EUDAMED 4199b030-1a2f-42f4-822c-992197e9d343 61 fields · synced Jul 19, 2026