Eu Mdr Eu Md Class 2b On The Market

Comil

COMIL è un sistema utile in caso di disturbi dispeptici, gonfiore gastrointestinale, aerofagia e coliche gassose causate da disbiosi intestinale e in cui è necessario associare un dispositivo medico, utile a diminuire la tensione superficiale del lume enterico, ed un probiotico, utile a ripristinare la flora intestinale.

Devices (same UDI-DI)
4
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
08055748844012
Basic UDI-DI Code
805574884FTKMDR14ET
Reference
FT.K.MDR.14.4
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2b
Status
On The Market

Additional Description

Contents of the package: • 1 stickpack sachet of 2 grams of Comil Sachet, a food supplement consisting of Saccharomyces Boulardii and Maltodextrins. S. Boulardii is useful to promote the balance of the intestinal flora and can be taken by dispersing the contents of the sachet in at least 20 ml of water or directly in the medical device Comil Oral Drops. • Comil Oral Drops medical device consisting of a 20 ml bottle with dropper pump containing an emulsion of Simeticone (with 40 mg/ml) in aqueous solution with Sodium benzoate, Potassium sorbate, Sodium Saccharin, Cellulose gum, Citric acid, Silicium and Aroma, indicated in the treatment and prevention in case of: Dyspeptic disorders, Gastroenteric meteorism, Aerophagia and gas colic in infants, children and adults.

Medical Purpose

COMIL è un sistema utile in caso di disturbi dispeptici, gonfiore gastrointestinale, aerofagia e coliche gassose causate da disbiosi intestinale e in cui è necessario associare un dispositivo medico, utile a diminuire la tensione superficiale del lume enterico, ed un probiotico, utile a ripristinare la flora intestinale.

CND Nomenclature Codes

Code Description
G0401 ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS

Related Devices

The Basic UDI-DI associated with this device has 4 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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