Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

bioXtra SUCHO V ÚSTACH GÉLOVÝ ÚSTNY SPREJ

UDI-DI 05425005128415Basic UDI-DI 542500512BXMS01ZV

Class IIa · MDR · Lifestream Pharma N.V.

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Identification

Model: bioXtra Dry Mouth Gel Mouthspray 50ml
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 05425005128316
bioXtra BOCA SECA SPRAY BUCAL EN GEL 05425005128514
bioXtra DRY MOUTH GEL MOUTHSPRAY 05425005128019
bioXtra KUIVA SUU GEELISUUSUIHKE 05425005128217
bioXtra XEROSTOMIA SPRAY GEL ORALE 05425005128118

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/bioxtra-sucho-v-ustach-gelovy-ustny-sprej-8415 · UDI page: /udi/05425005128415

All devices from Lifestream Pharma N.V.

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