Univet Optical Technologies S.r.l.
Italian manufacturer of safety eyewear, laser eyewear and surgical loupes producing Made-in-Italy…
Italian manufacturer of safety eyewear, laser eyewear and surgical loupes producing Made-in-Italy magnification glasses and protective optics exported to the US, Canada and Brazil.
- Type
- Manufacturer
- Location
- Rezzato, Italy
- Founded
- 1988
- Website
- univet.it
- Categories
- Safety & Protective Equipment, Eyewear & Sunglasses, Medical & Healthcare Supplies
- Markets
- Italy, United States, Canada, Brazil, Germany
Verified facts
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- debarment-clear (green), checked 2026-08-12 OpenSanctions
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
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)
- Sunglasses and protective eyewear are personal protective equipment in the EU: CE marking under Regulation (EU) 2016/425 is required. European Commission (PPE)