Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

bioXtra XEROSTOMIA COLLUTORIO ULTRA DELICATO

UDI-DI 05425005129115Basic UDI-DI 542500512BXMR01ZQ

Class IIa · MDR · Lifestream Pharma N.V.

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Identification

Model: bioXtra Dry Mouth Ultra Mild Mouthrinse ( 250ml or 30ml)
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 05425005129818
bioXtra 05425005129313
bioXtra BOCA SECA ENJUAGUE BUCAL ULTRASUAVE 05425005129511
bioXtra DRY MOUTH ULTRA MILD MOUTHRINSE 05425005129627
bioXtra DRY MOUTH ULTRA MILD MOUTHRINSE 05425005129719
bioXtra DRY MOUTH ULTRA MILD MOUTHRINSE 05425005129016
bioXtra KUIVA SUU ERITTÄIN MIETO SUUVESI 05425005129214
bioXtra SUCHO V ÚSTACH JEMNÁ ÚSTNA VODA PRE 05425005129412

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/bioxtra-xerostomia-collutorio-ultra-delicato-9115 · UDI page: /udi/05425005129115

All devices from Lifestream Pharma N.V.

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