AliveDx Suisse SA
CH-MF-000024025 · Switzerland · Eysins
AliveDx Suisse SA is registered in the European database on medical devices as a manufacturer, with 27 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: 1x250, 4x85, 1x250, 4x85, 1x85, 4x85.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- Conjugate HRP
- Enhancement Reagent 1
- IgA Conjugate
- IgE Conjugate
- MosaiQ® AiPlex CTD
- MosaiQ® AiPlex CTD Quality controls
- MosaiQ® AiPlex CTDplus
- MosaiQ® AiPlex VAS
- MosaiQ® AiPlex VAS Quality Controls
- MosaiQ® Allergy Bet v 1
- Sample Diluent 2
- TMB Substrate
Showing 12 of 27 declared devices.
Catalogue references include 132001, 132020, 155002, 155041, 155050, 155055.
European nomenclature codes declared: W0580, W0102152011, W0102100199, W0102100499, W0102100699, W01020202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 27 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 27 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ALIVEDX SUISSE SA |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2026-07-30 |
Licence types: Test Kit (1), System (1).
Licensed under: MOSAIQ AIPLEX VAS, MOSAIQ 125.
North American profile: Canada only. AliveDx Suisse SA holds a Canadian licence but was not found in the U.S. register.