Zhejiang Crystal-Optech Co., Ltd.
Fabricante de filme óptico de precisão e revestimento AR/anti-reflexo para imagens médicas e instrumentos científicos.
A Crystal-Optech fabrica filmes finos ópticos de precisão, revestimentos AR, divisores de feixe, filtros ópticos e conjuntos de prismas usados em câmeras de endoscopia, lâmpadas de fenda oftálmicas, sistemas de imagem dentária, dispositivos de terapia a laser e espectrômetros científicos. A empresa também fornece óptica revestida para iluminação LED e aplicações de projeção em eletrônicos de consumo.
- Type
- Manufacturer
- Location
- Hangzhou, China
- Founded
- 2001
- Website
- crystal-optech.com
- Categories
- Suprimentos médicos e de saúde, Eletrônicos de consumo
- Markets
- China, Alemanha, Japão, Estados Unidos, Coreia do Sul
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 14001, Environmental 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)
- Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
- Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)