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.
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 | 2022-12-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AE-2743 | In distribution |
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| Hoffer Optical Zone Marker, With Cross Hairs, 4mm, Titanium | Aurora Surgical, LLC | 2 |
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| 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.