Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇹🇼 Taiwan
GlucoX Blood Glucose Monitoring System
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 04713106020044
- Basic UDI-DI Code
- B-04713106020044
- Reference
- TD-4183
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- TaiDoc Technology Corporation
Additional Description
This system is intended for use outside the body (in vitro diagnostic use) to quantitatively measure blood glucose in whole blood. It is for home use or for healthcare professional use. It should NOT be used for diagnosis or screening of diseases.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 052126 0069 | TÜV SÜD Product Service GmbH | Expired |
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