Identity
- Device Name
- Handheld Ultrasound Scanners EUDAMED
- Model / Reference
- SonoMe/SONOFINDER EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809276943781 EUDAMED
- Basic UDI-DI
- 880927694USSMWP EUDAMED
- Direct Marketing DI
- 08809276943781 EUDAMED
- EMDN Code
- Z11040106 HANDHELD ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Handheld Ultrasound Scanners by Bionet Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880927694USSMWP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bionet Co., Ltd.
- EUDAMED SRN
- KR-MF-000013439
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED e8ef8ef9-5e1c-4e32-9b85-b7254f088863 61 fields · synced Jun 18, 2026