Identity
- Trade Name
- U6 EUDAMEDU6 Exp EUDAMED
- Device Name
- Endoscopic Ultrasonic System EUDAMED
- Model / Reference
- U8 Exp EUDAMED-- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945868612627 EUDAMED06945868612610 EUDAMED
- Basic UDI-DI
- 69458686U1028SV 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
U6 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 | 69458686U1028SV | 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 fce0793d-eaab-4059-b380-9fa31273da2e 61 fields · synced Oct 8, 2026
- EUDAMED 7f21d0d4-6a24-428f-a5f0-3646d02e0856 61 fields · synced May 18, 2026