Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
On Call Sure Sync Blood Glucose Monitoring System
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-G115-10WJZ
- Basic UDI-DI Code
- B-G115-10WJZ
- Reference
- G115-10W
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
Additional Description
The On Call Sure Sync Blood Glucose Monitoring System is intended for quantitative measurement of glucose in venous, arterial, neonatal or fresh capillary whole blood from the fingertip, forearm and palm to monitor daily blood glucose for individuals who have diabetes or are potentially at risk for diabetes. The system includes On Call Sure Sync Blood Glucose Meters, On Call Sure Blood Glucose Test Strips and On Call Sure Glucose Control Solution.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
| W0101060101 | GLUCOSE TEST STRIPS |
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 042074 0026 | TÜV SÜD Product Service GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).
master diagnostica
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·VITRO, S.A.·On the market
Vitamin B1 & B6 Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Methylmalonic Acid Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Cortisol & Cortisone Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Vitamin A & E Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Metanephrines Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market