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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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Organization name
UDI-DI code
Reference / catalog number

90077439 — Class IIa MDR by Lifestream Pharma N.V.

MD Atlas
Lifestream Pharma N.V.

EUDAMED last updated this device on Apr 2, 2026

90077439

542500512BXMR01ZQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lifestream Pharma N.V.
UDI-DI code: 05425005129412
Reference / catalog number: 90077439

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Manufacturer information

Organization name: Lifestream Pharma N.V.
SRN: BE-MF-000001909
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Oct 3, 2023	Still on market
Slovakia	Oct 3, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05425005129412
Basic UDI-DI: 542500512BXMR01ZQ
Reference / catalog number: 90077439
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: bioXtra SUCHO V ÚSTECH ULTRA JEMNÁ ÚSTNÍ VODA Zvlhčuje, promazává a zklidňuje
Additional information URL: https://www.bioxtra.info/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

90077434542500512BXMR01ZQOn the market 90077414542500512BXMR01ZQOn the market 90077418542500512BXOG01YFOn the market 90077634542500512BXOG01YFOn the market 90077834542500512BXMS01ZVOn the market

Certificates

Certificate health across this manufacturer's portfolio.

BE23/00000293Supplemented
Quality management systemNotified body: 1639Expiry: Oct 3, 2028