Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇹🇼 Taiwan
ACEZIN AMIGold mini Blood Glucose Monitoring System
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 04719880650248
- Basic UDI-DI Code
- B-04719880650248
- Reference
- AM10 CD
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Ace Medical Technology Co., Ltd.
Additional Description
ACEZIN AMIGold mini blood glucose monitoring system is self-test medical device and intended for home testing or professional use to monitor the blood glucose (β-D-glucose) levels in fresh capillary whole blood from fingertip and venous whole blood. Venous blood tests can only be measured by professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
| W0101060101 | GLUCOSE TEST STRIPS |
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 105961 0002 | TÜV SÜD Product Service GmbH | Expired |
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