enable innovations s r l
Enable Innovations - gocce oculari, spray nasali e soluzioni per prodotti liquidi sterili.
Entra nella home page di Enable Innovations e scopri tutti i servizi di lavorazione per Dispositivi Medici di tutte le classi, integratori alimentari ed alimenti destinati a fini medici speciali.
- Type
- Manufacturer
- Location
- Carpi (MO), Italy
- Website
- https://www.enableinnovations.it
- Categories
- Pharmaceutical Manufacturing, Industrial Machinery, Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- state-aid-sector (green), checked 2026-05-22 Registro Nazionale degli Aiuti di Stato (rna.gov.it), open data
- web-presence-since (green), checked 2026-08-04 Internet Archive (Wayback)
- registered-manufacturer (green), checked 2026-08-10 Ministero della Salute, banca dati e Repertorio dei dispositivi medici
- export-registered (green), checked 2026-07-30 EU EORI validation (European Commission)
- vat-valid (green), checked 2026-08-01 VIES (European Commission)
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)
- Machinery sold in the EU needs CE marking with a declaration of conformity under the EU machinery rules. European Commission
- Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)
- No public registry exists for certificates of this kind in this sector: conformity is declared by the manufacturer. European Commission: CE marking, manufacturer's conformity assessment