bioXtra XEROSTOMIA GEL ORALE
Ref 90077632Model bioXtra Dry Mouth Oral Gel 40ml
Active
CE MDR
Valid until
3 Oct 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberBE23/00000293 | Date25 Nov 2025 | StatusActive |
Certificates
- BE23/00000293 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 25 Nov 2025
- Expires
- 3 Oct 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- bioXtra Dry Mouth
- Model / Reference
- bioXtra Dry Mouth Oral Gel 40ml, 90077632
- Primary DI / UDI-DI
- 05425005127111
- Basic UDI-DI
- 542500512BXOG01YF
- Direct Marketing DI
- 05425005127111
- EMDN Code
- V9017 Oral administration preparations not included in other classes
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- BE-MF-000001909
Other devices from Lifestream Pharma N.V.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No