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Organization name
UDI-DI code
Reference / catalog number

hysan Hypertonic Nasal Spray — Class IIa MDR

MD Atlas
URSAPHARM Arzneimittel GmbH

EUDAMED last updated this device on Jul 25, 2025

hysan Hypertonic Nasal Spray

4031626103064NH

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: URSAPHARM Arzneimittel GmbH
UDI-DI code: 04031626001542
Reference / catalog number: 55.1821

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Manufacturer information

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

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
If you use any other nasal sprays or nasal drops, there should be an interval of at least 30 minutes between the applications. hysan Hypertonic Nasal Spray should always be applied last.
CW999
hysan Hypertonic Nasal Spray should not be used if you are hypersensitive against any of the ingredients.

Market distribution

Primary placement in Malta; available across 1 country total.

Country	On market since	Until
MaltaPrimary placement	May 1, 2015	Still on market

Device identification

Trade name: hysan Hypertonic Nasal Spray
UDI-DI code: 04031626001542
Basic UDI-DI: 4031626103064NH
Reference / catalog number: 55.1821
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: hysan Hypertonic Nasal Spray is a sterile, hypertonic sea salt solution for nasal use.
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

Related devices

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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.