Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
SEJOY Blood Glucose Test Strips
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06939663914550
- Basic UDI-DI Code
- B-06939663914550
- Reference
- BS-102
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Sejoy Biomedical Co., Ltd.
Additional Description
The Sejoy BS-102 Test Strips are used with the Sejoy Blood Glucose Meters to quantitatively measure blood glucose withfresh capillary whole blood for self-testing. The blood glucose concentration of venous blood measured by healthcare professionalsThe fresh capillary whole blood collected from fingertip. The system isintended for in vitro diagnostic home-use or by healthcare professionain a clinical setting as an aid to monitor the effectiveness of diabetescontrol. This system is not for use in the diagnosis of diabetes mellitus.screening nor for testing newborns.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060101 | GLUCOSE TEST STRIPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 60149972 0001 | TÜV Rheinland LGA Products GmbH |
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