13001249

Trade name

not provided

UDI-DI code

08055267241538

Basic UDI-DI

80336618004060100000000TB

Reference / catalog number

13001249

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

• 10 MU48

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

• Q0299OPHTHALMIC DEVICES - OTHER

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 dropper to come into contact with the eye or other objects. • To avoid damage to the ocular surface, do not allow the dropper to come into contact with the eye while instilling the product. • As the solution in the bottle runs out, greater pressure will need to be applied for the drop to be dispensed. It is recommended that the optimum pressure is determined to avoid dispensing more than the amount indicated. • Close the bottle tightly after use. The cap has an inside coating that absorbs any residual drop. • No interactions of EDENORM 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 bottle is damaged. • Keep the product out of the 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. • Dispose of the sealed bottle with the remaining content according to your local waste management regulations.

No certificate specifically references this device's Basic UDI-DI.