Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- 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
Additional Description
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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| G030699 | DEVICES FOR THE NON-SURGICAL TREATMENT OF OBESITY - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | CE 652693 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).