Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
LabonaCheck™ A1c HbA1c Analyzer
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800065162406
- Basic UDI-DI Code
- B-08800065162406
- Reference
- MH200M10
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- GC MEDIS Corp.
Additional Description
LabonaCheck™ A1c HbA1c Analyzer is an in vitro diagnostic, POC(Point of care) device for professionals only who measure hemoglobin A1C in hospitals, clinical centers, and laboratories. Hemoglobin A1c as often called HbA1c, which is the combination of glucose and hemoglobin that carries oxygen in the red blood cells. Hemoglobin A1c is the glucose ratio in the blood and reflects the average glucose level over 2 to 3 months, therefore it is useful and a precise factor in long-term glucose level management.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060101 | GLYCOSILATED HEMOGLOBIN DEVICEs |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries