Stethoscope, Fetal
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Anhui, Jiangsu and Zhejiang: 4 hold an FDA registration. 1 is a contract manufacturer.
- Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
- Hefei Mlush Sanitary Products Co., Ltd. Anhui
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
- TF NEW Material SCI AND TEC Co., Ltd. Anhui
How Is HGN Classified?
Stethoscope, Fetal is FDA product code HGN, Class 1, 21 CFR 884.2900.
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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