Media, Reproductive
Who Makes This Device Type in China?
4 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Shandong.
- Dongguan King Medical Technology Co., Ltd. Guangdong, contract manufacturer
- Gimbo Medical Technology Shenzhen Co., Ltd. Guangdong
- Shandong Wego Ruisheng Medical Device Co., Ltd. Shandong
- Shenzhen VitaVitro Biotech Co., Ltd. Guangdong
How Is MQL Classified?
Media, Reproductive is FDA product code MQL, Class 2, 21 CFR 884.6180.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 17 clearances under this code; the FDA took a median of 182 days from receipt to decision on them.
What Do the Recalls Say?
The FDA has recorded 15 recalls under this product code since 2012. None was by a company in China. The root causes the FDA records most often are Packaging change control (2), Labeling Change Control (2) and Software design (2).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.