Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 04719882152061
- Basic UDI-DI Code
- B-04719882152061
- Reference
- LU700C / LU700L
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Leltek Inc.
Additional Description
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The modes of operation include B mode, M mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD)
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11040106 | HANDHELD ULTRASOUND SCANNERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | FI20/00010 | DNV Product Assurance AS |
Available In Countries
🇩🇪 Germany
🇮🇹 Italy
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