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Ultrasound Scanners
EUDAMEDClass IIa (EU MDR)
Ref Cetus 45ProModel Cetus series
Identity
- Trade Name
- ULTRASOUND SCANNERS EUDAMED
- Device Name
- Ultrasound Scanners EUDAMED
- Model / Reference
- Cetus series EUDAMEDCetus 45Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974676311569 EUDAMED
- Basic UDI-DI
- 697467631Cetus88 EUDAMED
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Ultrasound Scanners 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 | 697467631Cetus88 | 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 01561f64-6d30-41a1-be01-b8c1a9ffd3d8 61 fields · synced Oct 8, 2026