Oncobit AG
CH-MF-000037436 · Switzerland · Schlieren
Oncobit AG is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: 1.0, 1.0.0.
Authorised representative in the Union: MedEnvoy Global BV.
Devices declared under this manufacturer
- Oncobit PM Analyzer
- Oncobit PM BRAF V600E2 Control 10rxn
- Oncobit PM BRAF V600E2 PPM 40rxn
- Oncobit PM BRAF V600K PPM 200rxn
- Oncobit PM BRAF V600R PPM 40rxn
- Oncobit PM GNA11Q209L Control 10rxn
- Oncobit PM GNAQ209L Control 10rxn
- Oncobit PM GNAQ209P Control 10rxn
- Oncobit PM NRASQ61K Control 10rxn
- Oncobit PM NRASQ61K PPM 40rxn
- Oncobit PM NRASQ61L Control 10rxn
- Oncobit PM NRASQ61R Control 10rxn
Showing 12 of 28 declared devices.
Catalogue references include PM-1-01-02-1, PM-1-01-03-1, PM-1-01-04-2, PM-1-02-01-2, PM-1-03-01-2, PM-1-03-02-2.
European nomenclature codes declared: W01060299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 28 |
| 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 | 28 |
|---|---|
| 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. Oncobit AG was not found in either the U.S. or the Canadian register.