Hariomed
8 catalogue numbers from IW-A1800D, listed by HUA YUE Medical Technology Co., Ltd., China, under Assisted Reproduction Laminar Flow Workstation. 2 manufacturers in China are registered for this product code.
Assisted Reproduction Laminar Flow Workstation
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Guangdong and Hubei: 2 hold an FDA registration.
What Is This Device?
This product code is a class II exempt counterpart of MQG, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
How Is QKH Classified?
Assisted Reproduction Laminar Flow Workstation is FDA product code QKH, Class 2, 21 CFR 884.6120.
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.
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