Eu Mdr
Eu Md Class 2a
On The Market
🇳🇱 Netherlands
ESC 0-1 Hour Algorithm
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 08719327522776
- Basic UDI-DI Code
- 872029952642426RH
- Reference
- 2426
- 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 30-day acute myocardial infarction (AMI) in patients presenting with chest pain at the emergency department. The device uses results of a Troponin I measurement at presentation and its absolute 1h change to calculate the risk of AMI within 30 days.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V92 | MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES |
Available In Countries
🇳🇱 Netherlands
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