Identity
- Device Name
- Fetal monitor EUDAMED
- Model / Reference
- BT-350 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800012335006 EUDAMED
- Basic UDI-DI
- B-08800012335006 EUDAMED
- EMDN Code
- Z12080101 FOETAL MONITORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Fetal monitor by Bistos Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103545 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08800012335006 | 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 (2)
- EUDAMED 1febf5ca-d19e-413f-b613-44e17563ce44 85 fields · synced Jun 18, 2026
- FDA 510(k) K103545 1 fields · synced May 18, 2026