BIOPROD Biomedicinski produkti d.o.o.
Słoweński producent i eksporter przemysłowy
BIOPROD Biomedicinski produkti d.o.o. jest notowana przez Sloexport w innym sektorze produkcyjnym. Jej profil katalogowy opisuje działalność obejmującą produkcję sprzętu medycznego i chirurgicznego oraz środków ortopedycznych.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Ljubljana, Slovenia
- Website
- https://bioprod.si
- Categories
- Produkcja farmaceutyczna, Artykuły medyczne i związane z opieką zdrowotną, Maszyny Przemysłowe
- Markets
- Słowenia, Austria, Niemcy, Włochy, Chorwacja
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