Steriline S.r.l.
Aseptic filling and closing machines for injectable pharmaceuticals.
Steriline manufactures aseptic filling and closing machines for vials, syringes, ampoules, and cartridges for injectable drug manufacturing. The Como company exports complete aseptic fill-finish lines to pharmaceutical manufacturers in Europe, North America, and emerging markets.
- Type
- Manufacturer
- Location
- Como, Italy
- Founded
- 1987
- Website
- steriline.it
- Categories
- Medical & Healthcare Supplies, Industrial Machinery
- Markets
- Italy, Germany, United States, India, Japan
Verified facts
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- export-registered (green), checked 2026-07-30 EU EORI validation (European Commission)
- media-mention (green), checked 2026-07-18 Cleanroom Technology
- vat-valid (green), checked 2026-08-01 VIES (European Commission)
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- Good Manufacturing Practice
- CE Marking EU NANDO (notified bodies)
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
- 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