BIOPROD Biomedicinski produkti d.o.o.
Sloveense industriële fabrikant en exporteur
BIOPROD Biomedicinski produkti d.o.o. wordt door Sloexport vermeld in de overige maaksector. Het directoryprofiel beschrijft activiteiten, waaronder de productie van medische en chirurgische apparatuur en orthopedische geneesmiddelen.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Ljubljana, Slovenia
- Website
- https://bioprod.si
- Categories
- Farmaceutische productie, Medische en gezondheidszorgbenodigdheden, Industriële machines
- Markets
- Slovenië, Oostenrijk, Duitsland, Italië, Kroatië
Listed in a source registry
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- debarment-clear (green), checked 2026-08-05 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- sanctions-clear (green), checked 2026-08-05 - screened by name only: no legal entity is established for this record, so this is not a clearance 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)
- 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