Zhejiang Crystal-Optech Co., Ltd.
Precisiefabrikant van optische films en AR/antireflectiecoatings voor medische beeldvorming en wetenschappelijke instrumenten.
Crystal-Optech produceert precisie optische dunne films, AR-coatings, straalsplitsers, optische filters en prismaconstructies die worden gebruikt in endoscopiecamera's, oftalmologische spleetlampen, tandheelkundige beeldvormingssystemen, lasertherapie-apparaten en wetenschappelijke spectrometers. Het bedrijf levert ook gecoate optica voor LED-verlichting en projectietoepassingen in consumentenelektronica.
- Type
- Manufacturer
- Location
- Hangzhou, China
- Founded
- 2001
- Website
- crystal-optech.com
- Categories
- Medische en gezondheidszorgbenodigdheden, Consumentenelektronica
- Markets
- China, Duitsland, Japan, Verenigde Staten, Zuid-Korea
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)