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Organization name
UDI-DI code
Reference / catalog number

90077839 — Class IIa MDR by Lifestream Pharma N.V.

MD Atlas
Lifestream Pharma N.V.

EUDAMED last updated this device on Apr 2, 2026

90077839

542500512BXMS01ZV

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lifestream Pharma N.V.
UDI-DI code: 05425005128415
Reference / catalog number: 90077839

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Manufacturer information

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

Related devices

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

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: 05425005128415
Basic UDI-DI: 542500512BXMS01ZV
Reference / catalog number: 90077839
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 GELOVÝ ÚSTNÍ SPREJ 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

Certificates

Certificate health across this manufacturer's portfolio.

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