Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇹🇼 Taiwan
GlucoSure Advance II
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-47136487603C1TXX
- Basic UDI-DI Code
- B-47136487603C1TXX
- Reference
- S5640626 S5640680 S5640679 S5641126
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The GlucoSure ADVANCE II Blood Glucose Test Strip is intended to be used with the GlucoSure ADVANCE II Meter to quantitatively measure glucose in venous whole blood, neonatal whole blood, or capillary whole blood taken from fingertips, palm, or forearm. The GlucoSure ADVANCE II Blood Glucose Monitoring System is plasma-calibrated for easy comparison to lab results. It is intended for self-testing by people with diabetes and by healthcare professionals. It is not indicated for the diagnosis or screening of diabetes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| 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 |
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