Eu Mdd
Eu Md Class 2a
On The Market
π°π· South Korea
SONON 500L
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
Basic Information
- Primary DI
- 08809489920029
- Basic UDI-DI Code
- B-08809489920029
- Reference
- HC-BR-SON-EN
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Healcerion Co., Ltd.
Additional Description
The ultrasound device is a portable ultrasound scanner intended for use in professional healthcare environments, to obtain ultrasound echo images that can be used for clinical diagnostic purposes. The device is indicated for ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid).
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11040106 | HANDHELD ULTRASOUND SCANNERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 10000374940-PA-NA-KOR R | DNV Product Assurance AS | Expired |
Available In Countries
π©π° Denmark
π΅π± Poland
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