APPOLON BIOTECK
FR-MF-000022234 · France · CHAPONNAY
APPOLON BIOTECK is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- ABility Smart Extract
- HLAB27GUARD
- MTL
- RespiGUARD4plex
- SARS-CoV-2 RT-qPCR DETECTION KIT
- Smart GUARD
- ThromboGUARD FII FV
Catalogue references include AB0023, AB0024, AB0030, AB0038, AB0039, AB0096.
European nomenclature codes declared: W0105900101, W0106010401, W0106010115, W02050116, W0105041106, W050299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 11 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 10 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. APPOLON BIOTECK was not found in either the U.S. or the Canadian register.