Identity
- Trade Name
- Ultrasound Diagnostic System EUDAMED
- Device Name
- Ultrasound Diagnostic System EUDAMED
- Model / Reference
- Danus 8Exp EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974676310606 EUDAMED
- Basic UDI-DI
- 697467631FF060702K4 EUDAMED
- Direct Marketing DI
- 16974676310606 EUDAMED
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
Classification
- Device Class
- Class IIa 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
Ultrasound Diagnostic System by Focus&Fusion Healthcare (Hangzhou) 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 | 697467631FF060702K4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Focus&Fusion Healthcare (Hangzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000017932
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d63d43ad-a54d-4ff3-958d-5d6e05a808d4 61 fields · synced Oct 10, 2026