EU Manufacturer
🇹🇼 Taiwan
Active
General Life Biotechnology Co., Ltd.
SRN: TW-MF-000027109
·
Jhongjheng Rd. 6, 7F., No. 669, 242060 New Taipei City, Taiwan
Basic UDI-DIs
72
Total Devices
72
On Market
72
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Jhongjheng Rd. 6, 7F., No. 669, 242060 New Taipei City, Taiwan
- [email protected]
- Phone
- +886-2-2205-3698
- Website
- http://www.glbiotech.com.tw/
Regulatory Overview
Regulation
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Eu Ivdd
72
Classification
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Eu Ivd Self Testing
40
Eu Ivd Annex 2 List B
32
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2029595-1 | TÜV Rheinland LGA Products GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | HL 2029595-1 | TÜV Rheinland LGA Products GmbH | May 26, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| BeneCheck II Glucose Control Solution | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Blood Glucose Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Blood Glucose Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Blood Glucose Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Blood Glucose Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Glucose Test Strip | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Glucose Test Strip | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Glucose Test Strip | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Glucose Test Strip | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Glucose Test Strip | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Hb Hemoglobin Control Solution | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Hb Hemoglobin Control Solution | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Hb Hemoglobin Control Solution | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Hb Hemoglobin Test Strip | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck II Glucose Control Solution | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck II Glucose Control Solution | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Knight Blood Glucose & β-Ketone Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Knight Blood Glucose & β-Ketone Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Knight Blood β-Ketone Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Knight Blood β-Ketone Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Multi-Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Multi-Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Multi-Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck PLUS Multi-Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Premium Uric Acid Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Supreme Multi-Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Supreme Multi-Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Total Cholesterol Control Solution | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Total Cholesterol Control Solution | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Total Cholesterol Test Strip | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Total Cholesterol Test Strip | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Total Cholesterol Test Strip | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Total Cholesterol Test Strip | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Uni Blood Glucose Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Uni Blood Glucose Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Uni Blood Glucose Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Uni Blood Glucose Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| BeneCheck Uni Hemoglobin Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Uni Hemoglobin Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Uni Total Cholesterol Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Uni Total Cholesterol Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Uni Total Cholesterol Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Uni Total Cholesterol Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Uni Uric Acid Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Uni Uric Acid Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Uni Uric Acid Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Uni Uric Acid Monitoring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Uric Acid Control Solution | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Uric Acid Control Solution | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BeneCheck Uric Acid Control Solution | EU IVDD | Eu Ivd Self Testing | On Market | 1 |