Zhejiang Crystal-Optech Co., Ltd.
Produsen film optik presisi dan pelapis AR/anti-refleksi untuk pencitraan medis dan instrumen ilmiah.
Crystal-Optech memproduksi film tipis optik presisi, pelapis AR, pemecah sinar, filter optik, dan rakitan prisma yang digunakan dalam kamera endoskopi, lampu celah mata, sistem pencitraan gigi, perangkat terapi laser, dan spektrometer ilmiah. Perusahaan juga memasok optik berlapis untuk penerangan LED dan aplikasi proyeksi pada elektronik konsumen.
- Type
- Manufacturer
- Location
- Hangzhou, China
- Founded
- 2001
- Website
- crystal-optech.com
- Categories
- Perlengkapan Medis & Kesehatan, Elektronik Konsumen
- Markets
- Tiongkok, Jerman, Jepang, Amerika Serikat, Korea Selatan
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)