Bottle, Roller, Tissue Culture

Who Makes This Device Type in China?

7 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Anhui and Zhejiang.

Boen Healthcare Co., Ltd. Jiangsu
Citotest Labware Manufacturing Co., Ltd. Jiangsu
Citotest Scientific Co., Ltd. Jiangsu
Diatrust Medical Co., Ltd. Jiangsu
Hefei Juniushangmao Co., Ltd. Anhui
Suzhou Cellpro Biotechnology Co., Ltd. Jiangsu
Zhejiang Gongdong Medical Technology Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code KJC?

Bottle, Roller, Tissue Culture is FDA product code KJC, Class 1, 21 CFR 864.2240.

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.

Bottle, Roller, Tissue Culture

RegenET

Kit containing 20 x R-ET-3 in a carton box

Bottle, Roller, Tissue Culture

Corning

Corning Aseptic Transfer Cap for use with 850cm² Polystyrene Roller Bottle, 3/8” ID x 1/2” OD, 0.2 µm filter, MPC Quick Connect, Sterile, 1/bag, 2/box

Bottle, Roller, Tissue Culture

Who Makes This Device Type in China?

What Is FDA Product Code KJC?

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

RegenET

Corning

Where China Actually Supplies