Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇹🇼 Taiwan
Soludiab
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-T05G2J10012SNX6
- Basic UDI-DI Code
- B-T05G2J10012SNX6
- Reference
- SCLMV-BT
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Tyson Bioresearch, Inc.
Additional Description
The SCLMV-BT Control Solution is a desired aqueous glucose solution with small amounts of non-reactive ingredients and food coloring for verifying the accuracy of the entire LGLMV-BT-01 Blood Glucose Monitoring System. The control solutions are used to check the performance of the LGLMV-BT-01 meter, BRLMV-BT-01 test strips, and your testing technique. The LGLMV-BT-01 Blood Glucose Monitoring System is intended for use in the home self-testing and in professional settings to monitor blood glucose levels.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | C-02-1073-797-22 | Eurofins Electric & Electronics Finland Oy | 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