Plenity

Primary DI

08055162880009

Basic UDI-DI Code

B-08055162880009

Reference

MC0801-XX, MC0802-XX

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

Gelesis Srl

Plenity® Hydrogel is provided in porcine gelatin capsules size 00el. Plenity® is supplied in peelable blisters, each one providing the single dose of three (3) capsules, to be administered with water before lunch and dinner. The total amount of a single dose of administered hydrogel particles is 2.25 g twice per day. A monthly cardboard box contains a total number of 168 capsules in 56 pods for 28 days of therapy. Plenity® is available in two different packaging configurations, a monthly starter (welcome) kit and a monthly refill kit, both identified with a different catalog number.

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).