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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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bioXtra Dry Mouth — 6 UDI-DI variants, MDR (Lifestream Pharma N.V.)

MD Atlas
Lifestream Pharma N.V.

Data from EUDAMED, last updated May 23, 2026

bioXtra Dry Mouth

542500512BXMS01ZV

6 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Lifestream Pharma N.V.

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: BE23/00000293
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: SGS Belgium NV (1639)
Validity: Nov 25, 2025 → Oct 3, 2028

Identity & classification

Basic UDI-DI: 542500512BXMS01ZV
Device name: bioXtra Dry Mouth
Device model: bioXtra Dry Mouth Gel Mouthspray 50ml
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Oct 20, 2025

Manufacturer & authorised representative

Manufacturer

Name: Lifestream Pharma N.V.
SRN: BE-MF-000001909
Country: Belgium
Email: info@bioxtra.info
Phone: +32 64 66 50 92

Variants by status

UDI-DI variants

6 UDI-DI variants

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Applied filters

basicUdiUlid01K80DG3AD74GKJ0FF94RD3JNM

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

9007783405425005128316
9007784205425005128514
bioXtra DRY MOUTH GEL MOUTHSPRAY05425005128019
9007783305425005128217
9007783905425005128415
9007783205425005128118