Keeler Ltd.
Perusahaan desain dan manufaktur optik mata yang berbasis di Inggris yang memproduksi instrumen diagnostik, ...
Perusahaan desain dan manufaktur optik oftalmik yang berbasis di Inggris yang memproduksi instrumen diagnostik, kaca pembesar, dan peralatan optometri untuk pasar di AS, Australia, dan India.
- Type
- Manufacturer
- Location
- Windsor, United Kingdom
- Founded
- 1917
- Website
- keelerglobal.com
- Categories
- Perlengkapan Medis & Kesehatan, Kacamata & Kacamata Hitam
- Markets
- Inggris Raya, Amerika Serikat, Australia, India, Jerman
Verified facts
- domain-registered (green), checked 2026-08-02 Domain registry record
- ch-active (green), checked 2026-06-20 Companies House
- registered-manufacturer (green), checked 2026-06-20 Companies House
- directors-on-file (green), checked 2026-06-20 Companies House
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)