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Organization name
UDI-DI code
Reference / catalog number

55.1234 — Class IIb MDR by URSAPHARM Arzneimittel…

MD Atlas
URSAPHARM Arzneimittel GmbH

EUDAMED last updated this device on Mar 13, 2026

55.1234

4031626101888PR

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: URSAPHARM Arzneimittel GmbH
UDI-DI code: 04031626001924
Reference / catalog number: 55.1234

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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 56.00654031626551134RAOn the market EvoTears4031626551134RAOn 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

7 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
As pomadas oftálmicas devem ser utilizadas evitando o contacto da extremidade da bisnaga com o olho ou a pele.
CW999
Caso utilize VitA-POS durante o dia, a sua visão ficará comprometida durante algum tempo devido à consistência gordurosa da pomada. Até que isso desapareça, não deve conduzir, utilizar máquinas ou trabalhar sem apoio estável.
CW999
CONTRAINDICAÇÕES VITA-POS não deve ser: - aplicado se tiver hipersensibilidade a qualquer um dos componentes; - utilizado enquanto usa lentes de contacto; - aplicado diretamente após intervenção cirúrgica ou no caso de lesões agudas nos olhos uma vez que não existem estudos clínicos nestas indicações.

Market distribution

Primary placement in Portugal; available across 1 country total.

Country	On market since	Until
PortugalPrimary placement	Sep 1, 2017	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04031626001924
Basic UDI-DI: 4031626101888PR
Reference / catalog number: 55.1234
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: VitA-POS é uma pomada oftálmica estéril com Vitamina A para uso oftálmico.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02030399OPHTHALMOLOGY, VISCOELASTIC FLUIDS - OTHER

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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Manufacturing date
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