Gelesis srl
Gelesis - Thiết bị y tế dựa trên Hydrogel để kiểm soát cân nặng
Gelesis phát triển hydrogel siêu hấp thụ không mang tính hệ thống để kiểm soát cân nặng và các bệnh mãn tính liên quan đến GI, bao gồm cả Plenity.
- Type
- brand seeking distribution
- Location
- Calimera (LE), Italy
- Website
- https://www.gelesis.com
- Categories
- Sản xuất dược phẩm, Vật tư y tế và chăm sóc sức khỏe
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)