Ophthalmic Syringe

Which Manufacturers in China Make This?

3 manufacturers in China hold an FDA registration for this device type, based in Shanghai and Zhejiang.

Shanghai Kindly Enterprise Development Group Co., Ltd. Shanghai, contract manufacturer
Shanghai Mekon Medical Devices Co., Ltd. Shanghai
Zhejiang Kindly Medical Devices Co., Ltd. Zhejiang, contract manufacturer

What Is It?

An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to perform injections into the eye.

What Is FDA Product Code QLY?

Ophthalmic Syringe is FDA product code QLY, Class 2, 21 CFR 880.5860.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 193 days from receipt to decision.

Ophthalmic Syringe

StaClear

The StaClear Model SC250LL Syringe is a single-use piston syringe consisting of a graduated barrel with luer lock connector, plunger, and plunger gasket. It is non-toxic, non-pyrogenic, and…

Ophthalmic Syringe

VitreJect Ophthalmic Syringe

The VitreJect Ophthalmic Syringe is a manually operated syringe for fluid injection or withdrawal, including intracameral and intravitreal use. Healthcare professionals use it with a…

Ophthalmic Syringe

Which Manufacturers in China Make This?

What Is It?

What Is FDA Product Code QLY?

How Does It Reach the US Market?

StaClear

VitreJect Ophthalmic Syringe

Where China Actually Supplies