Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 08719327522745
- Basic UDI-DI Code
- 87202995264250XE
- Reference
- 250
- 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 6-week major adverse cardiac events (MACE) in patients presenting with chest pain at the emergency department. MACE is defined as acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) and death plus a combined endpoint of AMI, PCI, CABG and death.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V92 | MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES |
Available In Countries
🇳🇱 Netherlands
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