Zhejiang Crystal-Optech Co., Ltd.
用于医疗成像和科学仪器的精密光学薄膜和增透膜/抗反射涂层制造商。
Crystal-Optech 生产用于内窥镜相机、眼科裂隙灯、牙科成像系统、激光治疗设备和科学光谱仪的精密光学薄膜、增透膜、分束器、滤光片和棱镜组件。该公司还为消费电子产品中的 LED 照明和投影应用提供镀膜光学器件。
- Type
- Manufacturer
- Location
- Hangzhou, China
- Founded
- 2001
- Website
- crystal-optech.com
- Categories
- 医疗保健用品, 消费电子产品
- Markets
- 中国, 德国, 日本, 美国, 韩国
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)