Manufacturer
Bioteke
ChinaLegal entities : BioTeke Corporation（Wuxi）Co., Ltd
Markets : Austria · Belgium · Bulgaria · Croatia · Cyprus · Finland · France · Ireland · Spain · United States
Approvals : EU – class A, C · United States (FDA) – 510(k) : 2 · class I, II · latest in 2026 · see on the FDA website
EU representative : Medunion S.L. (Spain)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Virology - RT & POC - other | W0105099099 |
|
C IVDR, 98/79 | EUDAMED record Report an error |
| Samples collection devices - other | W05019099 | A IVDR | EUDAMED record Report an error | |
| IVD general use consumable devices - other | W0599 | A IVDR | EUDAMED record Report an error | |
| Nucleic acid testing apparatuses - rapid and point of care tests | W02050301 |
|
A IVDR | EUDAMED record Report an error |
| Automated sample transport systems | W02060102 | A IVDR | EUDAMED record Report an error | |
| Nucleic acid testing integrated extraction /amplification /detection systems | W02050116 |
|
A IVDR | EUDAMED record Report an error |
| Pipettes - other | W0503020199 | A IVDR | EUDAMED record Report an error | |
| Supplemental NA reagents | W0105900103 | A IVDR | EUDAMED record Report an error |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.