Eu Mdd
Eu Md Class 2a
On The Market
🇰🇷 South Korea
Sonovation1L, SOFRA1L, SonoInfra1L, Dr.SAFE, ACUFRIEND, ACUGUIDE,ACUWARY, AcuViz Pocket, Sono Cloud 1, eZono1000, eZ1L
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 08800076600119
- Basic UDI-DI Code
- B-08800076600119
- Reference
- SC1
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- FCU Co., Ltd.
Additional Description
The SC1 Ultrasound Imaging System (Model: SC1) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid).SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11040106 | HANDHELD ULTRASOUND SCANNERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1434-MDD-365/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
🇩🇪 Germany
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