BIOPROD Biomedicinski produkti d.o.o.
Slovenian industrial manufacturer and exporter
BIOPROD Biomedicinski produkti d.o.o. is listed by Sloexport in the other manufacturing sector. Its directory profile describes operations including Production of medical and surgical equipment and orthopaedic remedies.
- Type
- Manufacturer
- Location
- Ljubljana, Slovenia
- Website
- https://bioprod.si
- Categories
- Pharmaceutical Manufacturing, Medical & Healthcare Supplies, Industrial Machinery
- Markets
- Slovenia, Austria, Germany, Italy, Croatia
Listed in a source registry
Verified facts
- debarment-clear (green), checked 2026-08-05 OpenSanctions
- sanctions-clear (green), checked 2026-08-05 OpenSanctions
- web-presence-since (green), checked 2026-08-05 Internet Archive (Wayback)
- 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
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)