Device, Measuring, Lens Radius
Maloney Keratometer Titanium
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (2), Beijing (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Gino Optical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Hilsinger Trading (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 4 |
Record
| Listed by | Katena Products, Inc., United States |
|---|---|
| FDA product code | HLF |
| Device type | Device, Measuring, Lens Radius, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1430 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-14 |
| Record revised | 2022-12-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K3-7888 | In distribution |
Same Product Code
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| LRI/Toric Markers | Aurora Surgical, LLC | 13 |
| Corneal Markers | Aurora Surgical, LLC | 12 |
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| PRK, LASIK, Lasek, IntraLasik and Flap Management Instruments | Aurora Surgical, LLC | 11 |
| Hoffer Optical Zone Marker | Aurora Surgical, LLC | 9 |
| Dsek Markers | Aurora Surgical, LLC | 4 |
| Lasik Markers | Aurora Surgical, LLC | 3 |
| Medetz Surgical Instruments | Medetz Surgical Instruments | 3 |
| Centration Marker | Aurora Surgical, LLC | 3 |
| Hoffer Optical Zone Marker, With Cross Hairs, 4mm, Titanium | Aurora Surgical, LLC | 2 |
| Toric IOL Axis Marker w/2.5mm Radial, For Use with Beveled Degree Gauge, Titaniu | Aurora Surgical, LLC | 2 |
| Corneal Transplant Markers | Aurora Surgical, LLC | 2 |
Showing 12 of 49. All products under Device, Measuring, Lens Radius, Ophthalmic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.