Lifestream Pharma N.V.
Active in EUDAMEDBelgiumfrom SRN EUDAMED FDA SRN BE-MF-000001909 FEI 3012328521
- Devices
- 23
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Lifestream Pharma N.V. makes
The company manufactures topical oral gels, sprays, and rinses designed to relieve dry mouth symptoms, including severe xerostomia and mild oral dryness. Products include gel formulations for direct application, ultra-mild mouthrinses, and localized sprays targeting specific areas of the mouth. Some variants are tailored for sensitive oral conditions, while others are formulated for broader symptomatic relief.
These devices are classified under Class IIa in the EU regulatory framework and are registered in the eudamed database. The portfolio is listed under the European Union’s medical device regulations, ensuring compliance with EU requirements for non-invasive, low-risk oral care products.
Catalogue
Search and filter all 23 devicesCompany details
- EUDAMED SRN
- BE-MF-000001909
- FDA FEI number
- 3012328521
- EU VAT number
- 0471383178
- EUDAMED status
- Active
- EUDAMED registered name
- Lifestream Pharma N.V.
- Registered address
- 69, Rue Jules Bordet, 7180, Seneffe, Belgium
- Website
- www.bioxtra.info
- [email protected]
- Phone
- +32 64 66 50 92
- PRRC contact
- Anne Sophie Grell
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 3 Oct 2028
SGS Belgium NV 1639 1 certificate
- BE23/00000293 Active
Quality management system EU MDR
- Issued
- 25 Nov 2025
- Expires
- 3 Oct 2028
- Reason
- Other
Frequently asked questions
How many devices does Lifestream Pharma N.V. have in the registry?
The registry currently lists 23 devices for Lifestream Pharma N.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lifestream Pharma N.V.'s devices?
Among its 23 most recently registered devices, Lifestream Pharma N.V. has devices listed in EUDAMED (23 devices).
What risk classes do Lifestream Pharma N.V.'s devices fall under?
Among its 23 most recently registered devices, the classes recorded for Lifestream Pharma N.V.'s devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Lifestream Pharma N.V.?
EUDAMED lists 1 certificate for Lifestream Pharma N.V. (quality management system) under MDR. The most recent was issued on 25 Nov 2025.
What are the newest devices from Lifestream Pharma N.V. in the registry?
The most recently registered devices listed for Lifestream Pharma N.V. include bioXtra KUIVA SUU GEELISUUSUIHKE, bioXtra Dry Mouth Oral Gel, bioXtra DRY MOUTH GEL MOUTHSPRAY and bioXtra KUIVA SUU SUUGEELI.