Identity
- Trade Name
- SternMed GmbH EUDAMED
- Device Name
- Diagnostic Ultrasound System EUDAMED
- Model / Reference
- Sonos 10 / Sonos 12 EUDAMED1001040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251730800392 EUDAMED
- Basic UDI-DI
- 42517308010KV EUDAMED
- Direct Marketing DI
- 04251730800392 EUDAMED
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) 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
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SternMed GmbH by SternMed GmbH — 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 | 42517308010KV | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SternMed GmbH
- EUDAMED SRN
- DE-MF-000015421
Sources (1)
- EUDAMED aa7ca6bd-fccc-4a88-bdbd-0cd8ae9b9b21 61 fields · synced Jun 18, 2026