ITVN10

Organization name

Nirial Pharma srl

SRN

IT-MF-000018760

Manufacturer status

Active

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

• CW275

  In pregnancy and breastfeeding, consult your doctor first.
• CW010

  EUDAMED did not publish a description for this code.
• CW007

  Before the first use, check that the product is properly closed and not damaged.
• CW277

  If you experience any side effects, stop using the product, contact your doctor and inform the manufacturer.
• CW999

  Drug interactions: No drug interactions are known. The use of other ophthalmic product (drugs or medical device) should be done at least 15 minutes after the instillation of this eye spray. The oral administration of other medical devices, drugs or supplements concomitantly with this eye spray should be carried out under the supervision of a doctor. Contraindications: Sensitivity or known allergy to any ingredient. Precautions and warnings: For contact lens wearers: the product should be used between wears. DO NOT SPRAY ON OPEN EYES. In case of direct contact with the open eye, the product may cause a mild burning sensation, which disappears quickly with no after effects. If the burning sensation persists, rinse eyes with plenty of water. Any serious accident occurring in relation to the device must be promptly reported to the manufacturer and the competent authority of the Member State where the user and / or patient is established. Do not use the product in case of hypersensitivity or known allergy to one or more of its ingredients. Keep away from children's sight and reach. The use in children must be supervised by an adult. Product for external use only.

Primary placement in Türkiye; available across 1 country total.

Trade name

not provided

UDI-DI code

08052990632183

Basic UDI-DI

805299063OFTASPRAY001KC

Reference / catalog number

ITVN10

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• Q0299OPHTHALMIC DEVICES - OTHER