Miyoshi Aspirating Speculum
Catalogue number AE-1014AN, listed by Katena Products, Inc., United States, under Specula, Ophthalmic. 11 manufacturers in China are registered for this product code.
Specula, Ophthalmic
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Jiangsu and Shandong: 11 hold an FDA registration. 2 are contract manufacturers.
- 66 Vision Tech Co., Ltd. Jiangsu
- Asol Co., Ltd. Jiangsu
- Belle Healthcare Technology Co., Ltd. Jiangsu
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
- Huaian Frimen Co., Ltd. Jiangsu
- Huaian Tisurg Medical Instruments Co., Ltd. Jiangsu, contract manufacturer
- Huaian Wolfram Surgical Instruments Jiangsu
- Malosa Medical Instruments (Changshu) Limited Jiangsu, contract manufacturer
- Ophsurin Co., Ltd. Jiangsu, contract manufacturer
- Sihong Ophsurin Co., Ltd. Jiangsu
- Xinhua Surgical Instrument Co., Ltd. Shandong
How Is HNC Classified?
Specula, Ophthalmic is FDA product code HNC, Class 1, 21 CFR 886.4350.
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.
What Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2024. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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