Novacel Optical
法国处方眼科镜片制造商经营欧洲大型现代镜片之一……
法国处方眼科镜片制造商，经营欧洲大型现代化镜片实验室之一，服务于法国、比利时和瑞士市场。
- Type
- Manufacturer
- Location
- Chateau-Thierry, France
- Founded
- 1958
- Website
- novacel-optical.com
- Categories
- 眼镜和太阳镜, 医疗保健用品
- Markets
- 法国, 比利时, 瑞士, 西班牙, 德国
Verified facts
- domain-registered (green), checked 2026-08-10 Domain registry record
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)