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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

55.0396 — Class IIa MDR by URSAPHARM Arzneimittel…

MD Atlas
URSAPHARM Arzneimittel GmbH

EUDAMED last updated this device on Nov 3, 2025

55.0396

4031626101365NL

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: URSAPHARM Arzneimittel GmbH
UDI-DI code: 04031626002051
Reference / catalog number: 55.0396

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Manufacturer information

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

Related devices

55.14114031626101365NLOn the market EvoTears4031626551134RAOn the market 56.00654031626551134RAOn 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

6 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
Om du använder någon annan nässpray eller näsdroppar ska det gå minst 30 minuter mellan appliceringarna. Återfuktande Nässpray Apofri ska alltid appliceras sist.
CW999
Använd inte Återfuktande Nässpray Apofri om du är överkänslig mot något av innehållsämnena.

Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	Oct 1, 2011	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04031626002051
Basic UDI-DI: 4031626101365NL
Reference / catalog number: 55.0396
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: Återfuktande Nässpray Apofri är en steril lösning med natriumhyaluronat och dexpantenol för nasal användning.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q030103NASAL IRRIGATION 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