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Diagnostic ultrasound system
EUDAMEDClass IIa (EU MDR)
Ref 1080001001Model Venus Ultimate-Dual
Identity
- Device Name
- Diagnostic ultrasound system EUDAMED
- Model / Reference
- Venus Ultimate-Dual EUDAMED1080001001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974405092424 EUDAMED
- Basic UDI-DI
- 697440509CMUS01LS EUDAMED
- Direct Marketing DI
- 06974405092424 EUDAMED
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Diagnostic ultrasound system by Carbon (Shenzhen) Medical Device 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 | 697440509CMUS01LS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Carbon (Shenzhen) Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000031536
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 7ffae6d0-5730-43e8-988f-fa7c77f54373 61 fields · synced Sep 17, 2026