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Organization name
UDI-DI code
Reference / catalog number

56.0065 — Class IIb MDR by URSAPHARM Arzneimittel…

MD Atlas
URSAPHARM Arzneimittel GmbH

EUDAMED last updated this device on Jul 8, 2025

56.0065

4031626551134RA

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: URSAPHARM Arzneimittel GmbH
UDI-DI code: 04031626001450
Reference / catalog number: 56.0065

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Manufacturer information

Organization name: URSAPHARM Arzneimittel GmbH
SRN: DE-MF-000007748
Manufacturer status: Active

Related devices

55.14114031626101365NLOn the market 55.03964031626101365NLOn the market EvoTears4031626551134RAOn the market EvoTears4031626551134RAOn the market 55.17154031626551134RAOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

5 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW262
EUDAMED did not publish a description for this code.
CW999
Non disponendo ancora di dati sulla sicurezza relativamente all’uso in gravidanza, durante l’allattamento e nei bambini, l’uso di EvoTears® non è raccomandato. L’uso di EvoTears® richiede particolare cautela se lo si usa contemporaneamente ad altri trattamenti per l’occhio. Se si usa qualsiasi altro collirio è consigliabile aspettare almeno 30 minuti dopo l’applicazione prima di poter applicare EvoTears®. EvoTears® dovrebbe essere utilizzato per ultimo. Non utilizzare unguenti oculari durante il trattamento con EvoTears®. Se si portano le lenti a contatto, non utilizzare EvoTears®, perché non sono disponibili dati sufficienti sulla compatibilità di EvoTears® con i materiali che compongono le lenti a contatto. EvoTears® non deve essere impiegato in caso di ipersensibilità (allergia) verso il perfluoroesilottano. Non bere il liquido.

Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Dec 1, 2018	Still on market
Portugal	Dec 1, 2018	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04031626001450
Basic UDI-DI: 4031626551134RA
Reference / catalog number: 56.0065
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: EvoTears® è un dispositivo medico contenente un collirio liquido senza acqua, privo di fosfati e conservanti.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02030206EYE LUBRICANT SOLUTIONS

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

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Expiration date
Manufacturing date
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Software identification