OPTOTEK razvoj in proizvodnja optične in laserske opreme d.o.o.
Fabricante y exportador industrial esloveno
OPTOTEK razvoj in proizvodnja optične in laserske opreme d.o.o. cotiza en Sloexport en el otro sector manufacturero. Su perfil de directorio describe operaciones que incluyen que Optotek desarrolla y produce sistemas láser y dispositivos ópticos para aplicaciones en medicina (oftalmología) y sistemas de administración de láser (brazos articulados) para aplicaciones en medicina, ciencia e industria.
- Type
- Manufacturer
- Location
- Brnik - Aerodrom, Slovenia
- Website
- https://optotek-medical.com
- Categories
- Fabricación farmacéutica, Suministros médicos y sanitarios
- Markets
- Eslovenia, Austria, Alemania, Italia, Croacia
Listed in a source registry
Verified facts
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- domain-registered (green), checked 2026-08-09 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)
- 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)