FT.MDR.16.8.50

Trade name

not provided

UDI-DI code

08055748843435

Basic UDI-DI

805574884FTCE16-267U

Reference / catalog number

FT.MDR.16.8.50

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

COMIL is a product made up of: a bottle of 50 ml with bulb dropper containing an emulsion of Simethicone (40 mg/ 20 drops) in water solution.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• G99GASTROINTESTINAL DEVICES - OTHER

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

• CW999

  The device is not subject to special precautions of use, we note, however: - Do not use the product more than 30 days - The product may appear with two separate phases. After stirring the same should appear as a homogeneous emulsion. - Keep out of reach of children. - Do not exceed recommended dose. - Do not use after the expiration date, the expiry date refers to the product intact and properly stored. - Do not use if package is not intact. - All the components that make up the product including the dropper must be intact. - After a short period of treatment (7 days) with no significant results, consult a doctor - In case of adverse reactions suspend the use of the product and consult your doctor to fix a proper therapy. - During use, if you find the dropper dirty, clean it properly before inserting it into the bottle to prevent possible contamination. - Do not use in cases of suspected intestinal or ileus perforation. - In case of a serious accident occurring in relation to the medical device report the incident to the Manufacturer and the Competent Authority.

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