Eu Mdd Eu Md Class 2a On The Market ๐Ÿ‡ฎ๐Ÿ‡น Italy

Makrogol 3350 balance

S.I.I.T. srl ยท ๐Ÿ‡ฎ๐Ÿ‡น Italy
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1

Basic Information

Primary DI
D-060080867G
Basic UDI-DI Code
B-060080867G
Reference
2659655
Device Types
Single use
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
S.I.I.T. srl

Additional Description

Makrogol 3350 balance is a laxative medical device that, through osmotic action, regulates the bowels in a natural way. It is not absorbed nor ferments in the gut, does not irritate the mucosa and is eliminated in the faeces. Makrogol 3350 balance is particularly suitable in cases of occasional and chronic constipation. In fact, thanks to its affinity for water, Makrogol 3350 balance softens stools facilitating the evacuation without causing cramps or abdominal pain, or emergency conditions. Its effectiveness is not reduced over time. 1.1 Components Each sachet contains: functional ingredient: Macrogol 3350. 2. Package Makrogol 3350 balance comes in powder for oral solution. The box contains X disposable sachets. 3. Dosage and method for use Children > 2 to 11 year (from 12 kg to 20 kg): 1-2 sachets (10 g each) per day. Children over 11 years and adults (or above 20 kg): 1-3 sachets (10 g each) per day.

CND Nomenclature Codes

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

Certificates

Type Number
MDD Annex V 095-02-06-DM

Available In Countries

๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ต๐Ÿ‡ฑ Poland

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