NG Biotech SAS
FR-MF-000016216 · France · Guipry-Messac
NG Biotech SAS is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Devices declared under this manufacturer
- NG PRECISION +
- NG Precision+
- NG-TEST Blood Culture PREP
- NG-TEST CTX-M Multi
- NG-TEST MCR-1
- NG-TEST® HCG Whole Blood
- NG-TEST® hCG Blood Precision
- NG-Test CARBA 5
- Test de Grossesse Sanguin
- neosana
Showing 12 of 30 declared devices.
Catalogue references include NGB-CTM-S23-016, NGB-HCG-W21-013, NGB-HCG-W21-016, NGB-HCG-W21-017, NGB-HCG-W21-018, NGB-HCG-W23-023.
European nomenclature codes declared: W0102160302, W0102160399, W010407, W010499.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NG BIOTECH (FR) · FDA 3012516784 |
| Devices in EUDAMED | 30 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 30 |
|---|---|
| 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: United States only. NG Biotech SAS is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
D1395900026 | supplemented | 2030-03-26 |
D1395900023 | issued | 2030-03-26 |