OneLife SA
BE-MF-000003821 · Belgium · Louvain-la-neuve
OneLife SA is registered in the European database on medical devices as a manufacturer, with 51 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 51 |
|---|
Devices declared under this manufacturer
- Detect 2 kit
- Medizyme 3 Plus 5L
- enziDent Flow 2x5L
- enziMed ALLKLEAN 200L
- enziMed Pre-Cleaner 5L
- enziMed Pre-Cleaner 6x750mL
- enziMed Prevent MAX 200L
- enziMed Prevent MAX 6x1L
- enziMed Prevent SP 20L
- enziMed Prevent SP 5L
- enziMed Standard 10L
- enziMed Standard 20L
Showing 12 of 51 declared devices.
Catalogue references include OL20306, OL20508, OL20510, OL20530, OL21513, OL22215.
European nomenclature codes declared: D0801, D99, Z12011399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 51 |
| Country of registration | Belgium |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 51 |
|---|---|
| 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. OneLife SA was not found in either the U.S. or the Canadian register.