FOTONA proizvodnja optoelektronskih naprav d.d.
Slovenian industrial manufacturer and exporter
FOTONA proizvodnja optoelektronskih naprav d.d. is listed by Sloexport in the other manufacturing sector. Its directory profile describes operations including Production of medical laser systems for dermatology, gynecology and dentistry.
- Type
- Manufacturer
- Location
- Ljubljana, Slovenia
- Founded
- 1964
- Website
- https://fotona.com
- Categories
- Pharmaceutical Manufacturing, Medical & Healthcare Supplies
- Markets
- Slovenia, Austria, Germany, Italy, Croatia
Listed in a source registry
Verified facts
- 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
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
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)