Identity
- Trade Name
- X11 Super EUDAMEDX11 EUDAMED
- Device Name
- Digital Color Doppler ultrasound System EUDAMED
- Model / Reference
- X11 Exp EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945868610173 EUDAMED06945868610197 EUDAMED
- Basic UDI-DI
- 69458686U1024SM EUDAMED
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
X11 Super 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 | 69458686U1024SM | 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 (2)
- EUDAMED ccc2b8a7-0328-41cc-afd5-e22fafc0279d 61 fields · synced Oct 6, 2026
- EUDAMED cb7f13f0-4695-4530-8aee-74c4eca77e4d 61 fields · synced Jul 20, 2026