Gelesis srl
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
Gelesis - 用于体重管理的水凝胶医疗设备
Gelesis 开发非全身性超吸收性水凝胶，用于体重管理和胃肠道相关慢性疾病，包括 Plenity。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Calimera (LE), Italy
- Website
- https://www.gelesis.com
- Categories
- 药品制造, 医疗保健用品
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 7 official records from 7 official sources are on file. 4 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- Business email on the company's own domain (record type: corporate-mail-on-domain) [our own observation, not an official record; status green] Shows the domain runs its own email rather than a free mailbox. It describes the domain, not who owns it. checked 2026-08-08. Mail server of the company domain
- Website domain registered (record type: domain-registered) [our own observation, not an official record; status green] Shows how long this web address has been registered. That is the age of the domain, not of the company: a domain can change owners. checked 2026-08-08. Domain registry record
- Registered with the U.S. FDA (active, renewed for the current year) (record type: fda-registered) [official record; status green] Registered with the US food and drug regulator, renewed for the current year. checked 2026-08-08. FDA
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. checked 2026-08-08. OpenSanctions
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. checked 2026-08-08. OpenSanctions
- Active legal entity ID (LEI) (record type: lei-active) [official record; status green] A global identifier used in finance; an active one is renewed yearly. checked 2026-08-23. GLEIF global LEI register (golden copy)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-09-17. Ministero della Salute, banca dati e Repertorio dei dispositivi medici
- EU customs identifier (EORI) active (record type: export-registered-eori) [official record; status green] An EORI number identifies the company to EU customs for imports, exports and transit. A valid number does not show that any shipment took place and is not a licence to export a particular product. checked 2026-08-08. EU EORI validation (European Commission)
- Sector of a state-aid measure received (record type: state-aid-sector) [official record; status green] Shows the state classified the aided work as manufacturing, which is not the same as the company's registered main activity. effective since 2026-03-24. Registro Nazionale degli Aiuti di Stato (rna.gov.it), open data
- EU VAT number valid for cross-border trade (record type: vat-valid) [official record; status green] The number is registered and active: we asked the EU VIES service and it answered yes. An invalid VAT number is the first sign an invoice comes from the wrong company. checked 2026-08-08. VIES
- Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. checked 2026-09-10. GLEIF Global LEI record
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)
Goods family established: 医疗保健用品 (the company's own text). The exact product, operation and trade route needed to determine a product-specific requirement are not established here. Product-specific import rules not established for the catalog category 药品制造: no record or company text names goods of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.