Unknown / Not in EUDAMED

Snapshot 2026-10-09 · Link to EUDAMED

bioXtra

UDI-DI 05425005127012Basic UDI-DI 542500512BXOG01YF

Class IIa · MDR · Lifestream Pharma N.V.

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Identification

Model: bioXtra Dry Mouth Oral Gel 40ml
EMDN: V9017
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

BE23/00000293

EU quality management system · unknown

Notified body: SGS Belgium NV (1639)

Valid from 2025-11-25 · Expiry 2028-10-03

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Lifestream Pharma N.V.

SRN BE-MF-000001909

BE · Seneffe

manufacturer

Related UDI-DIs

bioXtra 05425005127814
bioXtra BOCA SECA GEL BUCAL 05425005127524
bioXtra Dry Mouth Oral Gel 05425005127623
bioXtra Dry Mouth Oral Gel 05425005127029
bioXtra KUIVA SUU SUUGEELI 05425005127210
bioXtra SUCHO V ÚSTACH ÚSTNY GÉL 05425005127418
bioXtra XEROSTOMIA GEL ORALE 05425005127111

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/bioxtra-7012 · UDI page: /udi/05425005127012

All devices from Lifestream Pharma N.V.

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