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Organization name
UDI-DI code
Reference / catalog number

Nazar Acqua spray isotonica — Class IIa MDR by Cosmosol srl

MD Atlas
Cosmosol srl

EUDAMED last updated this device on May 22, 2026

Nazar Acqua spray isotonica

803344748SEAWATER_SPRAY8Y

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cosmosol srl
UDI-DI code: 08033447480236
Reference / catalog number: 410004828

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View device family (Basic UDI)

Manufacturer information

Organization name: Cosmosol srl
SRN: IT-MF-000030944
Manufacturer status: Active

Critical warnings

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

CW268
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW136
EUDAMED did not publish a description for this code.
CW139
EUDAMED did not publish a description for this code.
CW157
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: Nazar Acqua spray isotonica
UDI-DI code: 08033447480236
Basic UDI-DI: 803344748SEAWATER_SPRAY8Y
Reference / catalog number: 410004828
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: Isotonic nasal spray with seawater Medical device. Cleans the nose gently. Infants, children, adults. For daily hygiene of nasal cavities. Preservative-free. Respects the ozone layer. Contains trace elements and marine minerals. Dry air, sudden changes in temperature, air conditioning, smoke, pollution, allergies and infections can all trigger nasal hypersecretion, or reduce moisture levels of the mucous membranes. With its localised, non-aggressive effect, this isotonic nasal spray offers a solution for these problems by effectively cleaning and hydrating the nasal cavities. This isotonic nasal spray with seawater has been designed especially with the daily nasal hygiene of infants, children and adults. Nasal mucous membranes are gently washed and secretions are gradually removed, promoting fluidification whilst eliminating excess mucus. For those suffering from dryness and reddening it improves moisture levels, whilst in cases of rhinitis and sinusitis it gradually removes nasal secretions, thereby eliminating pollen, allergens, viruses and bacteria. It is suitable for the daily nasal hygiene of children and infants aged over two months, as it cleans nasal passages of children not yet able to blow their noses properly. It also helps keep children’s airways clear, helping them breathe more easily, making for a better night’s sleep and facilitating breastfeeding for infants.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08033447480236

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

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

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Related devices

Nazar Acqua spray ipertonica803344748SEAWATER_SPRAY8YOn 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.