Avalign
Boucheron Speculum Set Round, Small Set of Four OL 33mm(1 1/4")
9manufacturers in China registered for this device type
81catalogue 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 | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | EPY |
| Device type | Speculum, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-11-03 |
| Record revised | 2023-07-06 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VM104-2875 | In distribution | |
| VM104-2843 | In distribution | |
| VM101-8200 | In distribution | |
| VM104-2871 | In distribution | |
| VM101-8311 | In distribution | |
| VM101-8221 | In distribution | |
| VM101-8179 | In distribution | |
| VM101-8213 | In distribution | |
| VM104-2861 | In distribution | |
| VM101-8155 | In distribution | |
| VM101-8163 | In distribution | |
| VM101-8232 | In distribution | |
| VM101-8193 | In distribution | |
| VM101-8241 | In distribution | |
| VM101-8159 | In distribution | |
| VM101-8116 | In distribution | |
| VM101-8281 | In distribution | |
| VM101-82364 | In distribution | |
| VM101-8151 | In distribution | |
| VM101-8207 | In distribution | |
| VM101-8110 | In distribution | |
| VM104-2816 | In distribution | |
| VM104-2837 | In distribution | |
| VM104-2842 | In distribution | |
| VM104-2827 | In distribution | |
| VM101-82374 | In distribution | |
| VM104-2814 | In distribution | |
| VM104-2810 | In distribution | |
| VM101-8270 | In distribution | |
| VM104-2857 | In distribution | |
| VM101-8101 | In distribution | |
| VM101-8215 | In distribution | |
| VM101-8191 | In distribution | |
| VM104-2829 | In distribution | |
| VM104-2853 | In distribution | |
| VM101-8153 | In distribution | |
| VM104-2854 | In distribution | |
| VM101-8177 | In distribution | |
| VM101-8208 | In distribution | |
| VM101-8286 | In distribution | |
| VM101-8277 | In distribution | |
| VM104-2812 | In distribution | |
| VM104-2831 | In distribution | |
| VM101-8199 | In distribution | |
| VM104-2822 | In distribution | |
| VM104-2873 | In distribution | |
| VM101-8175 | In distribution | |
| VM104-2833 | In distribution | |
| VM101-9264 | In distribution | |
| VM101-8161 | In distribution | |
| VM104-2811 | In distribution | |
| VM101-8124 | In distribution | |
| VM101-8171 | In distribution | |
| VM101-8181 | In distribution | |
| VM104-2844 | In distribution | |
| VM101-8265 | In distribution | |
| VM104-2841 | In distribution | |
| VM104-2835 | In distribution | |
| VM101-8284 | In distribution | |
| VM101-8103 | In distribution | |
| VM101-82344 | In distribution | |
| VM101-8197 | In distribution | |
| VM101-8183 | In distribution | |
| VM101-8211 | In distribution | |
| VM101-8133 | In distribution | |
| VM101-8233 | In distribution | |
| VM101-8282 | In distribution | |
| VM101-8217 | In distribution | |
| VM101-8122 | In distribution | |
| VM101-8279 | In distribution | |
| VM101-8234 | In distribution | |
| VM101-8118 | In distribution | |
| VM101-8219 | In distribution | |
| VM101-8173 | In distribution | |
| VM101-8278 | In distribution | |
| VM101-8157 | In distribution | |
| VM101-8239 | In distribution | |
| VM104-2846 | In distribution | |
| VM104-2818 | In distribution | |
| VM104-2847 | In distribution | |
| VM101-8287 | 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.