Identity
- Trade Name
- ULTRASOUND PROBES EUDAMED
- Device Name
- ULTRASOUND PROBES EUDAMED
- Model / Reference
- EV10-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974676311224 EUDAMED
- Basic UDI-DI
- 697467631VolumeVL EUDAMED
- EMDN Code
- Z110402010202 CURVILINEAR TRANSCUTANEOUS MULTIDIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovakia 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ultrasound Probes 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 | 697467631VolumeVL | 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 cfb2ea81-0c99-4889-8e6e-2596e4a5b659 61 fields · synced Oct 8, 2026