Optiswiss AG
Switzerland's number-one ophthalmic lens manufacturer with over 250 employees serving customers i…
Switzerland's number-one ophthalmic lens manufacturer with over 250 employees serving customers in more than 20 countries, with primary markets in Germany, France and Canada.
- Type
- Manufacturer
- Location
- Basel, Switzerland
- Founded
- 1949
- Website
- optiswiss.com
- Categories
- Eyewear & Sunglasses, Medical & Healthcare Supplies
- Markets
- Switzerland, Germany, France, Canada, Austria
Verified facts
- domain-registered (green), checked 2026-08-02 Domain registry record
- places-goods-on-market (green), checked 2026-08-21 Swissmedic, swissdamed register of Swiss and Liechtenstein economic operators for medical devices
- registered-manufacturer (green), checked 2026-08-21 Swissmedic, swissdamed register of Swiss and Liechtenstein economic operators for medical devices
- operating-permit (green), checked 2024-08-29 SHAB, Swiss Official Gazette of Commerce
- sanctions-clear (green), checked 2026-07-21 OpenSanctions
- registry-active-global (green), checked 2026-07-21 Zefix (Swiss commercial registry)
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
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)