Identity
- Trade Name
- BU:TERA EUDAMED
- Device Name
- High Intensity Focused Ultrasound EUDAMED
- Model / Reference
- BU:TERA EUDAMEDIDS-UM-0821 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809578390269 EUDAMED
- Basic UDI-DI
- B-08809578390269 EUDAMED
- EMDN Code
- Z120610 ULTRASOUND THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Romania 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bu:tera by Ids 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-08809578390269 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ids Ltd.
- EUDAMED SRN
- KR-MF-000018259
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 463bdf4b-7476-4352-bb13-5a0f294958a5 61 fields · synced Jul 9, 2026