13001268

Organization name

Fidia Farmaceutici S.p.A.

SRN

IT-MF-000026988

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  • The product is for ophthalmic external use only (eye surface). • In order to avoid the risk of cross-infection, the product is intended to be used by a single patient only. • To avoid contaminating the solution, do not allow the single-dose container to come into contact with the eye or other objects. • To avoid damage to the ocular surface, do not allow the single-dose container to come into contact with the eye while instilling the product. • The product is in single-dose packaging. After administration, the sealed single-dose container with the remaining content should be disposed of in accordance with local requirements. • The product is in single-dose packaging. The volume contained in the single-dose container is for a single administration, since the product does not contain preservatives. Reuse of the residual content may cause ophthalmic infection and/or patient injury. • No interactions of TRIUM MONODOSE with drugs or other topical ophthalmic products are known; however, consult your physician in case of concomitant administration with other topical ophthalmic products for specific indications on timing of administration. • Do not use the product if the single-dose container or the aluminium pouch are damaged. • Keep the product out of sight and reach of children. • In case of any undesirable effects, discontinue use and seek medical advice. • Keep the box and the leaflet for the entire period of use of the device.

Primary placement in Italy; available across 1 country total.

Trade name

not provided

UDI-DI code

08055267241545

Basic UDI-DI

80336618004210200000000RH

Reference / catalog number

13001268

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

• 0.35 MU48

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

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

• Q02030206EYE LUBRICANT SOLUTIONS