Gauge, Lens, Ophthalmic

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Guangdong and Shanghai, and 1 other province: 9 hold an FDA registration.

Danyang Guanheng Optical, Inc Jiangsu
Danyang Shiquan Optical Co., Ltd. Jiangsu
Huaian Tisurg Medical Instruments Co., Ltd. Jiangsu, contract manufacturer
Jiangsu Taojing Co., Ltd. Jiangsu
Lianyungang Tiannuo Optical Instrument Co., Ltd. Jiangsu, contract manufacturer
Shanghai Lucidarx Optical LLC Shanghai, contract manufacturer
Shenzhen Xinrun Optical Company Limited Guangdong
Taizhou City K&W International Trade Co., Ltd. Jiangsu
Wenzhou Baibo Eyeglasses Co., Ltd. Zhejiang

What Is FDA Product Code HLN?

Gauge, Lens, Ophthalmic is FDA product code HLN, Class 1, 21 CFR 886.1420.

How Does It Reach the US Market?

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.

Gauge, Lens, Ophthalmic

Novo Surgical

mendez degree gauge, i.d. 12.0 mm

Gauge, Lens, Ophthalmic

Stephens Instruments

Mendez Axis Finder

Gauge, Lens, Ophthalmic

Rumex

Grooved Fine Mendez Degree Gauge, With 4 Grooves, 12.00/14.00 mm Diameters, Length 120 mm, Titanium

Gauge, Lens, Ophthalmic

Tiannuo / Tnmed

2 catalogue numbers from TN-153, listed by Lianyungang Tiannuo Optical Instrument Co., Ltd., China, under Gauge, Lens, Ophthalmic. 9 manufacturers in China are registered for this product code.

Gauge, Lens, Ophthalmic

Which Manufacturers in China Make This?

What Is FDA Product Code HLN?

How Does It Reach the US Market?

Novo Surgical

Stephens Instruments

Rumex

Tiannuo / Tnmed

Where China Actually Supplies