Eu Ivdd
Eu Ivd Annex 2 List B
No Longer On The Market
🇹🇼 Taiwan
GlucoSure Star
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-47136487699A08Q
- Basic UDI-DI Code
- B-47136487699A08Q
- Reference
- S70304, S70052, S70005, S70008
- 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
GlucoSure Star Blood Glucose Monitoring System is a portable, battery-powered device that measures the concentration of glucose in whole blood. GlucoSure Star blood glucose monitoring system is intended for quantitative measurement of glucose in fresh capillary whole blood taken from fingertips, palm, or forearm at specific points in time. It is designed for both home use by an individual and for use by healthcare professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
| W0101060101 | GLUCOSE TEST STRIPS |
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2100077-1 | TÃœV Rheinland LGA Products GmbH | Expired |
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