Identity
- Device Name
- Patient Monitor EUDAMED
- Model / Reference
- BT-770 EUDAMEDBT-740 EUDAMEDBT-720 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800012377006 EUDAMED08800012374005 EUDAMED08800012372001 EUDAMED
- Basic UDI-DI
- B-08800012377006 EUDAMEDB-08800012374005 EUDAMEDB-08800012372001 EUDAMED
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMEDSpain 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
Patient Monitor by Bistos Co., Ltd. — Class IIb — 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-08800012377006 | Class IIb | 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 739ea627-9d40-47ba-bf41-86945d023d89 61 fields · synced Jul 18, 2026
- EUDAMED 15fbaeb0-b1bc-4154-b7eb-1021a69d191e 61 fields · synced May 17, 2026
- EUDAMED 72c6ec1e-f0b6-46fb-9abe-73b1e7ec4450 61 fields · synced May 18, 2026