Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇹🇼 Taiwan
Spengler TB100
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-T05D5710004SNKZ
- Basic UDI-DI Code
- B-T05D5710004SNKZ
- Reference
- 745012
- 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 Spengler TB100 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 blood glucose monitoring system. The Spengler TB100 control solution test examines the performance of the Spengler TB100 glucose meter, Spengler TB100 test strip and your operating techniques.
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 |
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