genetic s p a
Genetic spa
Genetic SpA is a private and independent company dedicated to the research, development, manufacturing and marketing of innovative therapeutic solutions that can protect people's health and improve their quality of life. We are driven by passion in what we do best, namely scientific research and innovative pharmaceutical development, aimed at the manufacturing, on our own account and on behalf of third parties, of different pharmaceutical forms for medicinal specialties and medical devices.
- Type
- Manufacturer
- Location
- CASTEL SAN Giorgio (SA), Italy
- Website
- https://www.geneticspa.com
- Categories
- Pharmaceutical Manufacturing, Packaging & Printing Supplies, Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- domain-registered (green), checked 2026-08-08 Domain registry record
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- operating-permit (green), checked 2026-08-16 EudraGMDP manufacturing authorisation register (EMA)
- gmp-certified (green), checked 2026-01-30 EudraGMDP, EU register of GMP certificates (EMA)
Claimed certifications
- Good Manufacturing Practice
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)
- If the goods are paper, board or printed products, EU imports fall under the Deforestation Regulation (EUDR) due-diligence regime; packaging machinery itself does not. European Commission (EUDR)
- 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