Lifestream Pharma N.V.
BE-MF-000001909 · Belgium · Seneffe
Lifestream Pharma N.V. is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 23 |
|---|
Most frequent device types declared: bioXtra Dry Mouth Gel Mouthspray 50ml, bioXtra Dry Mouth Oral Gel 40ml, bioXtra Dry Mouth Ultra Mild Mouthrinse ( 250ml or 30ml).
Devices declared under this manufacturer
- bioXtra
- bioXtra BOCA SECA ENJUAGUE BUCAL ULTRASUAVE
- bioXtra BOCA SECA GEL BUCAL
- bioXtra BOCA SECA SPRAY BUCAL EN GEL
- bioXtra DRY MOUTH GEL MOUTHSPRAY
- bioXtra DRY MOUTH ULTRA MILD MOUTHRINSE
- bioXtra Dry Mouth Oral Gel
- bioXtra KUIVA SUU GEELISUUSUIHKE
- bioXtra KUIVA SUU ERITTÄIN MIETO SUUVESI
- bioXtra KUIVA SUU SUUGEELI
- bioXtra SUCHO V ÚSTACH JEMNÁ ÚSTNA VODA PRE
- bioXtra SUCHO V ÚSTACH ÚSTNY GÉL
Showing 12 of 23 declared devices.
Catalogue references include 90077415, 90077419, 90077432, 90077442, 90077631, 90077831.
European nomenclature codes declared: V9017.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | LIFESTREAM PHARMA N.V. (BE) · FDA 3012328521 |
| Devices in EUDAMED | 23 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 23 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 4.3 % |
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. Lifestream Pharma N.V. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
BE23/00000293 | supplemented | 2028-10-03 |