Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 08719327522769
- Basic UDI-DI Code
- 872029952641044QQ
- Reference
- 1044
- 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 healthcare professionals to estimate the risk of 30-day in-hospital mortality in patients with or highly suspected of having acute coronary syndrome (ACS), i.e. NSTEMI, STEMI-RT and STEMI-No RT patients. The device combines a patient’s Heart rate, Age, and a Systolic Blood Pressure measurement to calculate the risk of mortality.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V92 | MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES |
Available In Countries
🇳🇱 Netherlands
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).
Sterivap HP
Device
EU MDR
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·11 countries
Plurasil Situform, Refill
Device
EU MDR
·
Eu Md Class 2a
·4dentPro GmbH & Co. KG·On the market·9 countries
OTOPLAN
Device
EU MDR
·
Eu Md Class 2a
·CASCINATION AG·On the market·31 countries
3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT TRITON
Device
EU MDR
·
Eu Md Class 2a
·TOPCON CORPORATION·On the market·2 countries
Monoart® Adattatore per Aspirasaliva Adapter for Saliva Ejector Adapter für Speichelsauger
Device
EU MDR
·
Eu Md Class 2a
·EURONDA S.P.A.·On the market·30 countries
Monoart® Adattatore per Aspirasaliva Adapter for Saliva Ejector Adapter für Speichelsauger
Device
EU MDR
·
Eu Md Class 2a
·EURONDA S.P.A.·On the market·30 countries