Gelesis srl
Gelesis - Dispositifs médicaux à base d'hydrogel pour la gestion du poids
Gelesis développe des hydrogels superabsorbants non systémiques pour la gestion du poids et les maladies chroniques liées au système gastro-intestinal, notamment Plenity.
- Type
- brand seeking distribution
- Location
- Calimera (LE), Italy
- Website
- https://www.gelesis.com
- Categories
- Production pharmaceutique, Fournitures médicales et de santé
Listed in a source registry
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- domain-registered (green), checked 2026-08-08 Domain registry record
- fda-registered (green), checked 2026-08-08 FDA
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- state-aid-sector (green), checked 2026-03-24 Registro Nazionale degli Aiuti di Stato (rna.gov.it), open data
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- registered-manufacturer (green), checked 2026-08-10 Ministero della Salute, banca dati e Repertorio dei dispositivi medici
- export-registered (green), checked 2026-08-08 EU EORI validation (European Commission)
- vat-valid (green), checked 2026-08-08 VIES
Claimed certifications
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)