Gmate® Origin
Basic Information
- Primary DI
- 08809301167793
- Basic UDI-DI Code
- B-08809301167793
- Reference
- PG301-INT
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- GB Lifecare Co., Ltd.
Additional Description
Blood Glucose Monitoring System is intended for self-testing in diabetes management. It is used outside the body (in vitro diagnostic use) by layperson with diabetes at home and by healthcare professionals in clinical setting as an aid to monitor the effectiveness of diabetes control. This meter can test the glucose levels of blood from your fingertip, Upper arm, Forearm, Hand, Thigh or Calf. However, test results from sites other than the fingertip may differ from fingertip measurements. Consult your doctor or healthcare professional before testing blood from the Upper arm, Forearm, Hand, Thigh or Calf. Components: ① Blood Glucose Test Meter ② Test Strips ③ Lancing Device ④ Lancets ⑤ User’s Guide ⑥ Quick Guide ⑦ Test Strip insert ⑧ Log book ⑨ Carrying Case ⑩ Battery
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL60145538 | TÜV Rheinland LGA Products GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).