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-47136487603C163
- Basic UDI-DI Code
- B-47136487603C163
- Reference
- S70335 S70350 S70512 S70513 S70514
- 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 Monitoring System is intended for quantitatively measurement of glucose in venous whole blood, neonatal whole blood, or capillary whole blood drawn from fingertips, palm, or forearm. It is intended for in vitro diagnostic use by people with diabetes or by health care professionals, as an aid to monitor glucose level in diabetes mellitus. It is not indicated for diagnosis or screening of diabetes.
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) | HL2100077-1 | TÃœV Rheinland LGA Products GmbH | Expired |
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