Bausch + Lomb
Spec FAR Orig MDL Oval Oblq #4
9manufacturers in China registered for this device type
87catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Taizhou Honod Medical Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 7 |
| Yuyao Guangjing Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | EPY |
| Device type | Speculum, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-11-20 |
| Record revised | 2025-04-10 (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 |
|---|---|---|
| N0229 4 | In distribution | |
| N2106 | In distribution | |
| N0310 1BL | In distribution | |
| N0211 1 | In distribution | |
| N0231 3 | In distribution | |
| N0246 1 | In distribution | |
| N0310 0BL | In distribution | |
| N0236 2 | In distribution | |
| N0248 | In distribution | |
| N0211 3 | In distribution | |
| N0229 3 | In distribution | |
| N2112 | In distribution | |
| N0211 4 | In distribution | |
| N0246 2 | In distribution | |
| N0221 6 | In distribution | |
| ET4121 | In distribution | |
| N0256 3 | In distribution | |
| N0221 4 | In distribution | |
| N0228 1 | In distribution | |
| N0310 4BL | In distribution | |
| N0311 2BL | In distribution | |
| N0241 2 | In distribution | |
| N0241 4 | In distribution | |
| N0236 4 | In distribution | |
| N1699 V | In distribution | |
| N2108 | In distribution | |
| N0258 | In distribution | |
| N0227 2 | In distribution | |
| N2125 | In distribution | |
| N0236 1 | In distribution | |
| N0246 3 | In distribution | |
| N2182 | In distribution | |
| N2111 | In distribution | |
| N0241 1 | In distribution | |
| N0311 4BL | In distribution | |
| N0211 2 | In distribution | |
| N0247 | In distribution | |
| N2181 | In distribution | |
| N1280 | In distribution | |
| N2810 | In distribution | |
| N0311 3BL | In distribution | |
| N2191 | In distribution | |
| N0227 1 | In distribution | |
| N0229 1 | In distribution | |
| N0226 4 | In distribution | |
| N2192 | In distribution | |
| N0311 0BL | In distribution | |
| N2183 | In distribution | |
| N0231 4 | In distribution | |
| N0236 3 | In distribution | |
| N2102 | In distribution | |
| N0226 2 | In distribution | |
| N0256 2 | In distribution | |
| N0229 2 | In distribution | |
| N2122 | In distribution | |
| N0310 2BL | In distribution | |
| N2193 | In distribution | |
| N2124 | In distribution | |
| N0251 3 | In distribution | |
| N0238 | In distribution | |
| N2113 | In distribution | |
| N0228 3 | In distribution | |
| N0251 2 | In distribution | |
| N0256 1 | In distribution | |
| N2121 | In distribution | |
| N2116 | In distribution | |
| N0266 2 | In distribution | |
| N0237 | In distribution | |
| N0251 1 | In distribution | |
| N0311 00BL | In distribution | |
| N0241 3 | In distribution | |
| N2105 | In distribution | |
| N2101 | In distribution | |
| N0311 1BL | In distribution | |
| N0226 1 | In distribution | |
| N0226 5 | In distribution | |
| N2123 | In distribution | |
| N0310 3BL | In distribution | |
| N0266 1 | In distribution | |
| N2200 | In distribution | |
| N0226 3 | In distribution | |
| N0231 2 | In distribution | |
| N0266 3 | In distribution | |
| N0221 5 | In distribution | |
| N0261 2 | In distribution | |
| N0231 1 | In distribution | |
| N0310 00BL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 203 |
| Ambler Surgical | Ambler Surgical, LLC | 190 |
| Sklar® | Sklar Corporation | 180 |
| Aesculap | Aesculap AG | 170 |
| Boss Instruments | Boss Instruments, Ltd. | 161 |
| Fentex | Fentex medical GmbH | 157 |
| Millennium | Avalign Technologies, Inc. | 148 |
| Bear | Bear-ENT, LLC | 145 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 142 |
| BR Surgical, LLC | BR Surgical LLC | 133 |
| Surtex | Surtex Instruments Ltd | 110 |
| Jedmed | Jedmed Instrument Company | 106 |
Showing 12 of 260. All products under Speculum, Ent
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.