OPTOTEK razvoj in proizvodnja optične in laserske opreme d.o.o.
Produsen dan eksportir industri Slovenia
OPTOTEK razvoj in proizvodnja optične in laserske opreme d.o.o. terdaftar oleh Sloexport di sektor manufaktur lainnya. Profil direktorinya menjelaskan operasi termasuk Optotek yang mengembangkan dan memproduksi sistem laser dan perangkat optik untuk aplikasi dalam bidang kedokteran (oftalmologi) dan sistem pengiriman laser (lengan artikulasi) untuk aplikasi dalam bidang kedokteran, sains, dan industri.
- Type
- Manufacturer
- Location
- Brnik - Aerodrom, Slovenia
- Website
- https://optotek-medical.com
- Categories
- Manufaktur Farmasi, Perlengkapan Medis & Kesehatan
- Markets
- Slovenia, Austria, Jerman, Italia, Kroasia
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)