Device, Measuring, Lens Radius, Ophthalmic

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Shanghai, Beijing and Jiangsu, and 1 other province: 5 hold an FDA registration. 1 is a contract manufacturer.

Beijing Hongdee Corporation Beijing
Gino Optical (Shanghai) Co., Ltd. Shanghai
Hilsinger Trading (Shanghai) Co., Ltd. Shanghai
Shanghai Link Instruments Co., Ltd. Jiangsu
Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) Shaanxi, contract manufacturer

What Is FDA Product Code HLF?

Device, Measuring, Lens Radius, Ophthalmic is FDA product code HLF, Class 1, 21 CFR 886.1430.

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 2010. None was by a company in China. The root cause the FDA records most often is PMA (1).

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

Device, Measuring, Lens Radius, Ophthalmic

Bores Optical Zone Marker, 5.0mm

Catalogue number AS3-150-5.0, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Bores Optical Zone Marker, 6.0mm

Catalogue number AS3-150-6.0, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 3.75mm, Titanium

Catalogue number AS3-100T-3.75, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Keratometer

Maloney Astigmatism Keratometer

Device, Measuring, Lens Radius, Ophthalmic

Maloney Asigmatism Keratometer

Catalogue number AE-2743, listed by Katena Products, Inc., United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 7.5mm, Titanium

Catalogue number AS3-100T-7.5, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 5.5mm, Titanium

Catalogue number AS3-100T-5.5, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Bores Axis Marker Titanium

Catalogue number AS3-001T, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 8.0mm, Titanium

Hoffer Optical Zone Marker, With Cross Hairs,8.0mm, Titanium

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 8mm, Stainless

Catalogue number AS3-100S-8.0, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Corneal Trephines

9.0mm Corneal Trephine Blades

Device, Measuring, Lens Radius, Ophthalmic

Sapphire Universal & Side Port Knives

Sapphire Lancet Blade, .50mm Blade, Straight Handle

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 7mm, Stainless

Catalogue number AS3-100S-7.0, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 3.25mm, Titanium

Catalogue number AS3-100T-3.25, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Lasik Fixation Ring

Lasik Hinge Protector Fixation Ring, 11mm Inner Diameter, Swivel

Device, Measuring, Lens Radius, Ophthalmic

Bores Optical Zone Marker, 8.0mm

Catalogue number AS3-150-8.0, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 3mm, Titanium

Catalogue number AS3-100T-3.0, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Bores Optical Zone Marker, 5.25mm

Catalogue number AS3-150-5.25, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Bores Axis Marker

Catalogue number AS3-001, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 3.5mm, Titanium

Catalogue number AS3-100T-3.5, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 4.75mm, Titanium

Catalogue number AS3-100T-4.75, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Bores Optical Zone Marker

Bores Optical Zone Marker, 8.5mm, Stainless Steel

Device, Measuring, Lens Radius, Ophthalmic

Device, Measuring, Lens Radius

Maloney Keratometer Titanium

Device, Measuring, Lens Radius, Ophthalmic

Bores Optical Zone Marker, 7.0mm

Catalogue number AS3-150-7.0, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Bores Optical Zone Marker, 5.75mm

Catalogue number AS3-150-5.75, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Centration Marker

Whipple Capsulorhexis Centration Marker, Marks 5.5mm-6.0mm with Center Pointer, Stainless Steel Tips, Round Unique Grooved Titanium Handle

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 4.5mm, Titanium

Catalogue number AS3-100T-4.5, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Dsek Markers

Corneal DSEK Double Ended 8.5mm / 9.5mm Marker with Cross Hairs

Device, Measuring, Lens Radius, Ophthalmic

Marker

Nujits/Solomon Toric IOL Axis Marker w/5.0mm Optical Zone, For Use with Gimble Mendez Beveled Degree Gauge, Stainless Steel

Device, Measuring, Lens Radius, Ophthalmic

Blade Breakers AND Holders

Universal Chuck Handle, 10cm, Titanium

Device, Measuring, Lens Radius, Ophthalmic

Sterile,Single Use,Mendez Degree Gauge, Form 0to 180,internal Diameter 12.0mm

Catalogue number 558002, listed by Hasa Optix, Belgium, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 9.0mm, Titanium

Catalogue number AS3-100T-9.0, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Medetz Surgical Instruments

Gimbel-Mendez Beveled Degree Gauge with teeth, 5 Degree Ruler markings on top of Unique bevel (labeled at 30 Degree increments), Round Knurled Handle, 117mm Overall Length, Titanium (with…

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 6.0mm, Titanium

Catalogue number AS3-100T-6.0, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Lasek Instruments

LASEK Alcohol Cannula, Disc Shape

Device, Measuring, Lens Radius, Ophthalmic

Corneal Transplant Markers

Anis Suture Placement Marker, 8 Lines, 8.0mm Diameter, Stainless Steel

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 4.25mm, Titanium

Catalogue number AS3-100T-4.25, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

PRK, LASIK, Lasek, IntraLasik and Flap Management Instruments

Machat PRK/LASIK Flap Spatula, 2mm x 5mm Golf Club Shaped Blade with Semi-Sharp Outer Edges

Device, Measuring, Lens Radius, Ophthalmic

Corneal Markers

Osher-Neuman Low Profile Corneal Marker, 16 Lines, Stainless

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 9.5mm, Titanium

Catalogue number AS3-100T-9.5, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 8.5mm, Titanium

Catalogue number AS3-100T-8.5, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Toric IOL Axis Marker W/2.5mm Radial, for Use With Beveled Degree Gauge, Titaniu

Toric IOL Axis Marker w/2.5mm Radial, For Use with Beveled Degree Gauge, Stainless Steel

Device, Measuring, Lens Radius, Ophthalmic

Bores Optical Zone Marker, 9.0mm

Catalogue number AS3-150-9.0, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

Lasik Markers

Lasik Marker, with 3.5mm and 4.0mm Intersecting Circles, Titanium (Gulani Style)

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 4mm, Titanium

Hoffer Optical Zone Marker, With Cross Hairs, 4mm, Stainless

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker

Hoffer Optical Zone Marker, With Cross Hairs, 8.25mm, Stainless

Device, Measuring, Lens Radius, Ophthalmic

LASIK Cannulas

LASIK Interface Cannula, 25 Gauge With Spatulated Tip

Device, Measuring, Lens Radius, Ophthalmic

Mandel Keratometer

Catalogue number AE-2744, listed by Katena Products, Inc., United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

Device, Measuring, Lens Radius, Ophthalmic

LRI/Toric Markers

LRI Marker, 6mm & 8mm Chord Lengths, With Degree Gauge (Uses Dell/Gills Nomograms)

Device, Measuring, Lens Radius, Ophthalmic

Hoffer Optical Zone Marker, With Cross Hairs, 6.5mm, Titanium

Catalogue number AS3-100T-6.5, listed by Aurora Surgical, LLC, United States, under Device, Measuring, Lens Radius, Ophthalmic. 5 manufacturers in China are registered for this product code.

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