Zhejiang Crystal-Optech Co., Ltd.
Precision optical-film and AR/anti-reflection coating manufacturer for medical imaging and scientific instruments.
Crystal-Optech manufactures precision optical thin films, AR coatings, beam-splitters, optical filters, and prism assemblies used in endoscopy cameras, ophthalmic slit lamps, dental imaging systems, laser therapy devices, and scientific spectrometers. The company also supplies coated optics for LED lighting and projection applications in consumer electronics.
- Type
- Manufacturer
- Location
- Hangzhou, China
- Founded
- 2001
- Website
- crystal-optech.com
- Categories
- Medical & Healthcare Supplies, Consumer Electronics
- Markets
- China, Germany, Japan, United States, South Korea
Verified facts
- domain-registered (green), checked 2026-08-12 Domain registry record
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- debarment-clear (green), checked 2026-08-12 OpenSanctions
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)