Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇹🇼 Taiwan
GlucoSure Autocode
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-47136487601A05H
- Basic UDI-DI Code
- B-47136487601A05H
- Reference
- S70123, S70488
- 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 Autocode 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). It is intended for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitor levels in Diabetes Mellitus. It is not intended for the diagnosis or screening of diabetes or for neonatal use.
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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