EU Manufacturer
๐น๐ผ Taiwan
Active
Apex Biotechnology Corp.
SRN: TW-MF-000019773
ยท
No. 7, Li-Hsin Road V Hsinchu Science Park, Hsinchu, Taiwan, 30078 Hsinchu, Taiwan
Basic UDI-DIs
40
Total Devices
40
On Market
31
Off Market
9
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
11
Basic Information
- Address
- No. 7, Li-Hsin Road V Hsinchu Science Park, Hsinchu, Taiwan, 30078 Hsinchu, Taiwan
- [email protected]
- Phone
- +886 3 564 1952
Regulatory Overview
Regulation
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Eu Ivdd
40
Classification
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Eu Ivd Annex 2 List B
21
Eu Ivd Self Testing
11
Eu Ivd General
8
Device Types
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Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
4
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2100077-1 | TรV Rheinland LGA Products GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | HL 2100077-1 | TรV Rheinland LGA Products GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | HL2100077-1 | TรV Rheinland LGA Products GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | HL 2100077-1 | TรV Rheinland LGA Products GmbH | May 26, 2025 |
Market Presence
Devices from this manufacturer are available in 11 countries across Europe.
๐ง๐ช Belgium
๐จ๐พ Cyprus
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| KETOSURE POC | EU IVDD | Eu Ivd General | On Market | 0 |
| MultiSure GK | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| UASure II | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Contrex Plus 4 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Contrex Plus 5 | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Contrex Plus III | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Eclipse A1C | EU IVDD | Eu Ivd General | Off Market | 0 |
| Eclipse PLUS | EU IVDD | Eu Ivd General | Off Market | 0 |
| GlucoSure Advance II | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| GlucoSure Advance II | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| GlucoSure Autocode | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| GlucoSure Autocode | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| GlucoSure HT | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| GlucoSure HT | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| GlucoSure HT Link | EU IVDD | Eu Ivd Annex 2 List B | Off Market | 1 |
| GlucoSure Link | EU IVDD | Eu Ivd Annex 2 List B | Off Market | 1 |
| GlucoSure POC | EU IVDD | Eu Ivd General | Off Market | 0 |
| GlucoSure POC Compact | EU IVDD | Eu Ivd General | Off Market | 0 |
| GlucoSure Star | EU IVDD | Eu Ivd Annex 2 List B | Off Market | 1 |
| HemoSmart GOLD | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| HemoSmart GOLD | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| HemoSmart GOLD | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| KET-1 | EU IVDD | Eu Ivd Self Testing | Off Market | 1 |
| KETOSURE POC | EU IVDD | Eu Ivd General | On Market | 0 |
| KETOSURE POC | EU IVDD | Eu Ivd General | On Market | 0 |
| KETOSURE POC | EU IVDD | Eu Ivd General | On Market | 0 |
| MultiSure GCTU | EU IVDD | Eu Ivd Annex 2 List B | Off Market | 1 |
| MultiSure GK | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| MultiSure GK | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| MultiSure GK | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| MultiSure GK | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| THE EDGE | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| THE EDGE | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| THE EDGE | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| UASure | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| UASure II | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| UASure II | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Wellion AMADEUS | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Wellion AMADEUS | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Wellion AMADEUS | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |