GlucoSure Link
Basic Information
- Primary DI
- D-47136487601A15K
- Basic UDI-DI Code
- B-47136487601A15K
- Reference
- S70453, S70454, S70455
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- No Longer On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The GlucoSure Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Testing is done outside the body (In Vitro Diagnostic use). The GlucoSure Link Blood Glucose Monitoring System is plasma-calibrated for easy comparison to lab results. It is intended for self-testing to monitor and control blood glucose levels by people with diabetes mellitus; they can also be used in a clinical setting by healthcare professionals. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
| W0201060102 | BLOOD GLUCOSE METERS |
| W0101060101 | GLUCOSE TEST STRIPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2100077-1 | TÃœV Rheinland LGA Products GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).