BIA SEPARATIONS Podjetje za separacijske tehnologije d.o.o.
Slovenian industrial manufacturer and exporter
BIA SEPARATIONS Podjetje za separacijske tehnologije d.o.o. is listed by Sloexport in the chemicals and pharmaceuticals sector. Its directory profile describes operations including BIA Separations Ltd., located in Ajdovščina, Slovenia was founded by a group of scientists and venture capital investors with the purpose of developing innovative chromatographic material for the next century and the mission to become a market leader in the so-called monolithic technology. Today, BIA Separations manufa.
- Type
- Manufacturer
- Location
- Ajdovščina, Slovenia
- Website
- https://biaseparations.com
- Categories
- Pharmaceutical Manufacturing, Medical & Healthcare Supplies, Chemicals & Plastics
- Markets
- Slovenia, Austria, Germany, Italy, Croatia
Listed in a source registry
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-05 Mail server of the company domain
- domain-registered (green), checked 2026-08-05 Domain registry record
- web-presence-since (green), checked 2026-08-05 Internet Archive (Wayback)
- debarment-clear (green), checked 2026-08-05 OpenSanctions
- sanctions-clear (green), checked 2026-08-05 OpenSanctions
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)
- Chemical substances imported into the EU above 1 tonne/year must be REACH-registered. ECHA (REACH)
- 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)