Makrogol 3350 balance
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 | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | 095-02-06-DM | ITALCERT SRL | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).