Speculum, Vaginal, Metal, Fiberoptic
Who Makes This Device Type in China?
2 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.
- Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
How Is HDG Classified?
Speculum, Vaginal, Metal, Fiberoptic is FDA product code HDG, Class 1, 21 CFR 884.4520.
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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