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Sign in to claim this brandAPEX BIOTECHNOLOGY CORP.
Taiwan·TW-MF-000019773
Last updated September 17, 2026
Information
- Country
- Taiwan
- Address
- No. 7, Li-Hsin Road V Hsinchu Science Park, Hsinchu, Taiwan, Hsinchu, Taiwan
- Website
- apexbio.com
- —
- —
- [email protected]
- Phone
- +886 3 564 1952
- PRRC Contact
- Lisa Liu
- EUDAMED SRN
- TW-MF-000019773
- FDA FEI Number
- 3002671736
- DUNS Number
- —
Catalogue (70)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GlucoSure HT | S5640693, S5640758, S5640657, S5640895, S5640918, S5640659 | EUDAMED | IVD Annex II List B | Active |
| MultiSure GK | S5800192 | EUDAMED | IVD Annex II List B | Active |
| Eclipse A1C | S54133, S54144, S54145, S54119 | EUDAMED | IVD General | Active |
| GlucoSure Link | S70453, S70454, S70455 | EUDAMED | IVD Annex II List B | Active |
| Wellion AMADEUS | S5641137, S5641138 | EUDAMED | IVD Annex II List B | Active |
| GlucoSure HT | S70385 | EUDAMED | IVD Annex II List B | Active |
| GlucoSure Advance II | S5640626 S5640680 S5640679 S5641126 | EUDAMED | IVD Annex II List B | Active |
| GlucoSure HT Link | S70440, S70441, S70442 | EUDAMED | IVD Annex II List B | Active |
| HemoSmart GOLD | S5640254, S5640365, S5640733, S5640255, S5640682, S5640745 | EUDAMED | IVD devices for self-testing | Active |
| The Edge | S5800024 | EUDAMED | IVD devices for self-testing | Active |
| Wellion AMADEUS | S5800475, S5800476, S5800477 | EUDAMED | IVD Annex II List B | Active |
| Ketosure Poc | S5800358 | EUDAMED | IVD General | Active |
| GlucoSure POC Compact | S70466, S70467 | EUDAMED | IVD General | Active |
| UASure II | S5800386 | EUDAMEDFDA 510(k) | IVD devices for self-testing | Active |
| MultiSure GK | S84005 | EUDAMED | IVD Annex II List B | Active |
| MultiSure GK | S5640624, S5640451, S5640452 | EUDAMED | IVD Annex II List B | Active |
| Ket-1 | S11004, S11008, S11009 | EUDAMED | IVD devices for self-testing | Active |
| Ketosure Poc | S11015 | EUDAMED | IVD General | Active |
| Contrex Plus 4 | S5800308, S5800153, S5800309, S5800154, S5800310, S5800155 | EUDAMED | IVD Annex II List B | Active |
| UASure II | S5640955, S5640956 | EUDAMED | IVD devices for self-testing | Active |
Related Companies
Authorised Representatives
- Obelis s.a. BE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Apex Biotechnology Corp. US