Microscope, Phase Contrast

Which Manufacturers in China Make This?

4 manufacturers in China hold an FDA registration for this device type, based in Jiangsu and Zhejiang. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Carl Zeiss Suzhou Co., Ltd. Jiangsu
Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
Nanjing Nikon Jiangnan Optical Instrument Co., Ltd. Jiangsu, contract manufacturer
Ningbo Haishu District Proway IMP. & EXP. Co., Ltd. Zhejiang

How Is IBM Classified?

Microscope, Phase Contrast is FDA product code IBM, Class 1, 21 CFR 864.3600.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2013. None was by a company in China. The root cause the FDA records most often is No Marketing Application (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Microscope, Phase Contrast

Cision Vision

Catalogue number Cision InVision, listed by Cision Vision, United States, under Microscope, Phase Contrast. 4 manufacturers in China are registered for this product code.

Microscope, Phase Contrast

Van Gogh

Catalogue number Sample Holder Box, listed by Aquyre Biosciences Inc., under Microscope, Phase Contrast. 4 manufacturers in China are registered for this product code.

Microscope, Phase Contrast

Which Manufacturers in China Make This?

How Is IBM Classified?

What Does It Take to Sell It in the United States?

What Do the Recalls Say?

Cision Vision

Van Gogh

Where China Actually Supplies