OPTOTEK razvoj in proizvodnja optične in laserske opreme d.o.o.
Produttore industriale ed esportatore sloveno
OPTOTEK razvoj in proizvodnja optične in laserske opreme d.o.o. è quotata da Sloexport nell'altro settore manifatturiero. Il suo profilo di directory descrive operazioni tra cui Optotek sviluppa e produce sistemi laser e dispositivi ottici per applicazioni in medicina (oftalmologia) e sistemi di erogazione laser (bracci articolati) per applicazioni in medicina, scienza e industria.
- Type
- Manufacturer
- Location
- Brnik - Aerodrom, Slovenia
- Website
- https://optotek-medical.com
- Categories
- Produzione farmaceutica, Forniture medicali e sanitarie
- Markets
- Slovenia, Austria, Germania, Italia, Croazia
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)