Marker, Sclera

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Jiangsu and Hubei: 3 hold an FDA registration. 1 is a contract manufacturer.

Hubei Lanbin Medical Group Co., Ltd. Hubei, contract manufacturer
Malosa Medical Instruments (Changshu) Limited Jiangsu, contract manufacturer
Sihong Ophsurin Co., Ltd. Jiangsu

How Is HMQ Classified?

Marker, Sclera is FDA product code HMQ, Class 1, 21 CFR 886.4570.

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.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2025. None was by a company in China. The root cause the FDA records most often is Employee error (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Intravitreoretinal Caliper/Fixator

Catalogue number 90-1016, listed by Blink Medical Ltd, United Kingdom, under Marker, Sclera. 3 manufacturers in China are registered for this product code.

Marker Pad – Gentian Violet

Catalogue number 7303, listed by Hurricane Medical, United States, under Marker, Sclera. 3 manufacturers in China are registered for this product code.

Sontec 5d Arculate Marker

Sontec 5D Arculate Marker With Alignment Notches Round Handle Titanium

Vortex Surgical Inc.

Lindsell Sutured IOL Marker

Thorton Corneal Marker

Thorton Corneal Marker Single Ended Titanium

Dual Tip Marker Pen – Gentian Violet

Catalogue number 7319, listed by Hurricane Medical, United States, under Marker, Sclera. 3 manufacturers in China are registered for this product code.

Marker Pad – Methylene Blue

Catalogue number 7304, listed by Hurricane Medical, United States, under Marker, Sclera. 3 manufacturers in China are registered for this product code.

Scleral Marker

Gass Scleral Marker

Thornton Corneal Marker

Catalogue number T12-9101, listed by Sontec Instruments, Inc., United States, under Marker, Sclera. 3 manufacturers in China are registered for this product code.

Dual Tip Marker Pen – Methylene Blue

Catalogue number 7320, listed by Hurricane Medical, United States, under Marker, Sclera. 3 manufacturers in China are registered for this product code.

Bausch + Lomb

AWH Sutureless Sclerotomy GDE

Thornton TWO RAY Meridian Marker

Thornton TWO RAY Meridian Marker Single Ended Round Handle Titanium

Malosa Medical

Pointed IVT Marker 3.5/4.0mm Blue

Marker Double Ended 3.5mm-4mm

Catalogue number 90-1015, listed by Blink Medical Ltd, United Kingdom, under Marker, Sclera. 3 manufacturers in China are registered for this product code.

Stephens Instruments

Shepard-Hoffer Optic Zone Marker with Cross Hairs, 2.75mm

Braunstein Marker

Catalogue number 90-1017, listed by Blink Medical Ltd, United Kingdom, under Marker, Sclera. 3 manufacturers in China are registered for this product code.

MSI Precision Specialty Instruments

Gimbel-Mendez Beveled Degreega, Titanium, 11.7mm Internal Diameter, Measures 0-180 Degrees, 5 Degrees Increments, Labeled At 30 Degrees Increments, Ring Mounted At 0 Degrees, 36 Blunt Teeth…

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer