Minivette® Poct 20µl
Catalogue number 17.2111.020, listed by Sarstedt Aktiengesellschaft & Co.KG, under Tube, Collection, Capillary Blood. 16 manufacturers in China are registered for this product code.
Tube, Collection, Capillary Blood
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Jiangsu, Shandong and Zhejiang, and 5 other provinces: 16 hold an FDA registration. 2 are contract manufacturers.
- Anhui Kangda Medical Products Co., Ltd. Anhui, contract manufacturer
- Boen Healthcare Co., Ltd. Jiangsu
- Changshu Rozer Irradiation Technology Co., Limited Jiangsu, contract manufacturer
- Diatrust Medical Co., Ltd. Jiangsu
- Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
- Infitek Co., Ltd. Shanghai
- Jiangsu Changfeng Medical Industry Co., Ltd. Jiangsu
- Labpeak Co., Ltd. Shandong
- Medico Technology Co., Ltd. Guangdong, contract manufacturer
- Scitek Global Co., Ltd. Shandong
- Tianjin Newtrans Technology Development Tianjin
- Weihai Kangzhou Biotechnology Engineering Co., Ltd. Shandong
- Weihai Kangzheng Medical Equipments Technology Co., Ltd. Shandong, contract manufacturer
- Xiamen Zhiyuan Medical Technology Co., Ltd. Fujian, contract manufacturer
- Zhejiang Saining Biotechnology Co., Ltd. Zhejiang
- Zhejiang Gongdong Medical Technology Co., Ltd. Zhejiang, contract manufacturer
How Is GIO Classified?
Tube, Collection, Capillary Blood is FDA product code GIO, Class 1, 21 CFR 864.6150.
How Does It Reach the US Market?
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.
What Has Gone Wrong With It?
The FDA has recorded 25 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Process change control (13), Material/Component Contamination (4) and Process control (3).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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