Zhejiang Crystal-Optech Co., Ltd.
Produttore di pellicole ottiche di precisione e rivestimenti AR/antiriflesso per imaging medicale e strumenti scientifici.
Crystal-Optech produce pellicole ottiche sottili di precisione, rivestimenti AR, divisori di fascio, filtri ottici e gruppi di prismi utilizzati in telecamere per endoscopia, lampade oftalmiche a fessura, sistemi di imaging dentale, dispositivi di terapia laser e spettrometri scientifici. L'azienda fornisce anche ottiche rivestite per applicazioni di illuminazione e proiezione a LED nell'elettronica di consumo.
- Type
- Manufacturer
- Location
- Hangzhou, China
- Founded
- 2001
- Website
- crystal-optech.com
- Categories
- Forniture medicali e sanitarie, Elettronica di consumo
- Markets
- Cina, Germania, Giappone, Stati Uniti, Corea del Sud
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)