Identity
- Trade Name
- P12 EUDAMED
- Device Name
- Digital Color Doppler Ultrasound System EUDAMED
- Model / Reference
- P10 Exp EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945868602932 EUDAMED
- Basic UDI-DI
- 69458686U1003SD EUDAMED
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
P12 by Sonoscape Medical Corp. — 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 | 69458686U1003SD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sonoscape Medical Corp.
- EUDAMED SRN
- CN-MF-000009623
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c2933691-1e4d-4287-9653-07c1fdff8233 61 fields · synced Oct 7, 2026