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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

55.1715 — Class IIb MDR by URSAPHARM Arzneimittel…

MD Atlas
URSAPHARM Arzneimittel GmbH

EUDAMED last updated this device on Jul 8, 2025

55.1715

4031626551134RA

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: URSAPHARM Arzneimittel GmbH
UDI-DI code: 04031626001443
Reference / catalog number: 55.1715

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Manufacturer information

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

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
Din cauza lipsei informațiilor privind siguranța, în cazul femeilor însărcinate sau care alăptează și copiilor, utilizarea EvoTears® nu este recomandată. Fiți precauți cu utilizarea EvoTears® dacă folosiți în prezent alte medicamente pentru ochi. Dacă folosiți orice alte picături oftalmice, așteptați 30 de minute după aplicarea acestora, până la utilizarea EvoTears®. EvoTears® trebuie folosit întotdeauna ultimul. Unguentele oftalmice nu trebuie folosite în timpul tratamentului cu EvoTears®. Nu folosiți EvoTears® dacă purtați lentile de contact, pentru că nu există suficiente informații care să confirme compatibilitatea EvoTears® cu materialele lentilelor de contact. Nu utilizați EvoTears® dacă sunteți hipersensibil/ă (alergic/ă) la perfluorohexiloctan. Nu beți lichidul.

Market distribution

Primary placement in Romania; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04031626001443
Basic UDI-DI: 4031626551134RA
Reference / catalog number: 55.1715
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® este un dispozitiv medical care conține picături oftalmice lichide fără apă, fără conservanți și fără fosfați.
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

55.14114031626101365NLOn the market 55.03964031626101365NLOn the market EvoTears4031626551134RAOn the market 56.00654031626551134RAOn the market EvoTears4031626551134RAOn the market

Certificates

Certificate health across this manufacturer's portfolio.

HZ 1010771-1Supplemented
Quality management systemNotified body: 0197Expiry: Dec 12, 2029