Eu Ivdd
Eu Ivd General
No Longer On The Market
🇹🇼 Taiwan
GlucoSure POC
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-47136487603B05W
- Basic UDI-DI Code
- B-47136487603B05W
- Reference
- S84512, S84511
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The GlucoSure POC blood glucose and ketone monitoring system is intended to quantitatively measure blood glucose level and blood ketone level in venous whole blood or fresh capillary whole blood drawn from fingertips. The GlucoSure POC blood glucose and ketone monitoring system is intended for testing outside the body (in vitro diagnostic use). It is intended for use by healthcare professionals in laboratories such as physician office laboratories, clinics, and hospitals, as an aid in monitoring blood glucose level and blood ketone level in diabetes mellitus. It is not indicated for diagnosis or screening of diabetes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
| W020106019099 | VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER |
| W0101060101 | GLUCOSE TEST STRIPS |
| W0101060110 | KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS) |
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