Bausch + Lomb
Speculum Child Solid Barraquer
11manufacturers in China registered for this device type
55catalogue numbers in this listing
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 | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | HNC |
| Device type | Specula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-08-26 |
| Record revised | 2025-09-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E4106 K | In distribution | |
| E4064 | In distribution | |
| E4111 | In distribution | |
| E4107 PS | In distribution | |
| E4082 | In distribution | |
| E4108 | In distribution | |
| E4040 | In distribution | |
| E4100 | In distribution | |
| E3066 | In distribution | |
| E4105 | In distribution | |
| ET4065 | In distribution | |
| SP7-67424 | In distribution | |
| E4065 | In distribution | |
| E4007 | In distribution | |
| E4055 | In distribution | |
| E4067 | In distribution | |
| E4073 | In distribution | |
| E7165 | In distribution | |
| E4006 | In distribution | |
| E4106 N | In distribution | |
| E4051 | In distribution | |
| SP7-70641 | In distribution | |
| E4107 P | In distribution | |
| E4065AS | In distribution | |
| E4106 ST | In distribution | |
| E4041 | In distribution | |
| E4080 | In distribution | |
| E4122 | In distribution | |
| E4110 | In distribution | |
| SP7-70000 | In distribution | |
| E4058 | In distribution | |
| E4109 | In distribution | |
| E4106 H | In distribution | |
| E4112 | In distribution | |
| E4053 | In distribution | |
| E4106 S | In distribution | |
| SP7-72946 | In distribution | |
| E4056 | In distribution | |
| E9107 | In distribution | |
| E4106 KT | In distribution | |
| E4106 | In distribution | |
| E4118 T | In distribution | |
| E4050 | In distribution | |
| E4113 | In distribution | |
| ET4077 | In distribution | |
| E4072 | In distribution | |
| E4094 | In distribution | |
| E4121 | In distribution | |
| E4086 | In distribution | |
| E4065 A | In distribution | |
| E4106 T | In distribution | |
| E4054 R | In distribution | |
| E4107 | In distribution | |
| E7165 | In distribution | |
| E4107 K | 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 |
| Surtex | Surtex Instruments Ltd | 54 |
| Rumex | Rumex International Co. | 47 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 38 |
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.