Pediatric Solid Blade Speculum ADJ
Catalogue number AE-1055, listed by Katena Products, Inc., United States, under Specula, Ophthalmic. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (10), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Ophsurin Co., Ltd. | Suqian | Jiangsu | Contract manufacturer | 6 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
Record
| Listed by | Katena Products, Inc., United States |
|---|---|
| FDA product code | HNC |
| Device type | Specula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| 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 |
| Sizes | Length 5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AE-1055 | Length 5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MSI Precision Specialty Instruments | MED Saver, Inc. | 214 |
| Ambler Surgical | Ambler Surgical, LLC | 169 |
| Sklar | Sklar Corporation | 121 |
| Walcott Rx Products | Walcott Rx Product Inc | 115 |
| Ophthalmic Speculum | Aurora Surgical, LLC | 93 |
| MR Phaco | Crestpoint Management Ltd. | 84 |
| Millennium | Avalign Technologies, Inc. | 79 |
| Ophthalmic Speculum | Katena Products, Inc. | 76 |
| Stephens Instruments | Krishna Imports Inc | 61 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 55 |
| Surtex | Surtex Instruments Ltd | 54 |
| Rumex | Rumex International Co. | 47 |
Showing 12 of 360. All products under Specula, 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.