Euphralia Yeux Secs et Irrités

Organization name

C.O.C. FARMACEUTICI S.R.L.

SRN

IT-MF-000019321

Manufacturer status

Active

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

• CW262

  Product is for single patient use [EN].
• CW999

  If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
• CW999

  Dispose of the product according to your local waste management regulations.
• CW999

  Do not use if are visible particles and/or changes in the colour of the solution.
• CW275

  Consult your doctor before you use this product if you are pregnant or breast-feeding [EN].
• CW032

  Do not use the product after the expiry date indicated on the package and on the label [EN].
• CW999

  It is necessary to report any serious incident occurred in relation to the device to the manufacturer and the Competent authority of the Member state in which you are established.
• CW007

  Do not use the product if the container results, at the time of first opening, damaged or not perfectly sealed [EN].
• CW999

  For external use, do not swallow.
• CW999

  Do not use the product in case of hypersensitivity towards any of the components of the solution and/or Asteraceae plants and/or Compositae plants and/or Hamamelidaceae plants and/or Orobanchaceae plants.
• CW999

  The product is for ophthalmic use only.
• CW999

  Keep out of reach of children.
• CW999

  During application, do not touch the eye or any other surface with the container’s dispensing edge.
• CW999

  In case of side effects during use, interrupt the treatment and consult a doctor.
• CW999

  Do not try to tamper or disassemble the nozzle from the bottle.

Primary placement in Belgium; available across 2 countries total.

Trade name

Euphralia Yeux Secs et Irrités

UDI-DI code

08057729510374

Basic UDI-DI

803395976DT01DT011ZC

Reference / catalog number

DT/01/DT/011

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