FOTONA proizvodnja optoelektronskih naprav d.d.
Fabricante e exportador industrial esloveno
FOTONA proizvodnja optoelektronskih naprav d.d. é listada pela Sloexport no outro setor manufatureiro. Seu perfil de diretório descreve operações que incluem a produção de sistemas médicos de laser para dermatologia, ginecologia e odontologia.
- Type
- Manufacturer
- Location
- Ljubljana, Slovenia
- Founded
- 1964
- Website
- https://fotona.com
- Categories
- Fabricação farmacêutica, Suprimentos médicos e de saúde
- Markets
- Eslovênia, Áustria, Alemanha, Itália, Croácia
Listed in a source registry
Verified facts
- lei-active (green), checked 2026-08-07 GLEIF global LEI register (golden copy)
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- domain-registered (green), checked 2026-08-08 Domain registry record
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
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)
- 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)