XPER Technology PREMIUM Multi-Functional Monitoring System
Basic Information
- Primary DI
- 04710469877438
- Basic UDI-DI Code
- B-04710469877438
- Reference
- TD-4216
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- TaiDoc Technology Corporation
Additional Description
This system is intended for use outside the body (in vitro diagnostic use) to quantitatively measure the biochemical parameter - blood glucose, β-ketone, total cholesterol, triglycerides, uric acid and lactate in fresh capillary whole blood. It is for self-testing or for healthcare professional use. It should NOT be used for diagnosis or screening of diseases. Professionals may also use the test strips for blood glucose measurement in venous, arterial, neonatal whole blood and for β-ketone, lactate measurement in venous whole blood. Self-testing is limited to doing all biochemical parameter testing with fresh capillary whole blood.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02010199 | CHEMISTRY INSTRUMENTS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 052126 0069 | TÜV SÜD Product Service GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).