Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 08719327522783
- Basic UDI-DI Code
- 872029952642903RW
- Reference
- 2903
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Evidencio
Additional Description
The device is intended to be used by physicians to estimate the risk of 10-year first hard ASCVD events (defined as first occurrence of nonfatal myocardial infarction, CHD death, or fatal or nonfatal stroke). The device combines Sex, Age, Race, Cholesterol and HDL-Cholesterol, Systolic Blood pressure, and personal history regarding diabetes, smoking, and hypertension treatment to calculate the 10-year risk of ASCVD.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V92 | MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES |
Available In Countries
🇳🇱 Netherlands
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