Cystoscope
28 catalogue numbers from 165 303 001, listed by Sopro-Comeg GmbH, Germany, under Cystoscope And Accessories, Flexible/Rigid. 16 manufacturers in China are registered for this product code.
16manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (3), Hunan (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Ningbo Wise Optomech Technology Corporation | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Zhejiang Tiansong Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 4 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
Showing 12 of 16. All 16 manufacturers in China registered for Cystoscope And Accessories, Flexible/Rigid
Record
| Listed by | Sopro-Comeg GmbH, Germany |
|---|---|
| FDA product code | FAJ |
| Device type | Cystoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K945262 |
| Record published | 2018-03-20 |
| Record revised | 2023-11-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 165 303 001 | In distribution | |
| 165 271 872BC001 | In distribution | |
| 165 403 005BC001 | In distribution | |
| 165 293 000 | In distribution | |
| 165 303 002BC001 | In distribution | |
| 165 271 870 | In distribution | |
| 161 271 140BC001 | In distribution | |
| 165 403 002BC001 | In distribution | |
| 161 271 140 | In distribution | |
| 165 293 001BC001 | In distribution | |
| 165 271 870BC001 | In distribution | |
| 165 293 002BC001 | In distribution | |
| 165 403 001 | In distribution | |
| 165 293 000BC001 | In distribution | |
| 165 303 001BC001 | In distribution | |
| 165 403 000BC001 | In distribution | |
| 165 211 870 | In distribution | |
| 165 403 005 | In distribution | |
| 165 293 002 | In distribution | |
| 165 271 875BC001 | In distribution | |
| 165 303 002 | In distribution | |
| 165 293 001 | In distribution | |
| 165 403 000 | In distribution | |
| 165 403 002 | In distribution | |
| 165 271 872 | In distribution | |
| 165 403 001BC001 | In distribution | |
| 165 271 875 | In distribution | |
| 165 211 870BC001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AED | National Advanced Endoscopy Devices, Inc. | 157 |
| Strauss Surgical | American Medical Endoscopy | 112 |
| Cystoscope And Accessories, Flexible/Rigid | Stryker GmbH | 61 |
| Hopkins | Karl Storz GmbH & Co. KG | 50 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 50 |
| Cystoscopy sheath | Sopro-Comeg GmbH | 42 |
| Cystoscopy instrument | Sopro-Comeg GmbH | 42 |
| Cystoscopy obturator | Sopro-Comeg GmbH | 41 |
| OES Elite | Olympus Winter & IBE Gmbh | 39 |
| Cystoscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 39 |
| Accessory for urology | Sopro-Comeg GmbH | 34 |
| Single-Use Flexible Cystoscope | Hunan Vathin Medical Instrument Co., Ltd. | 28 |
Showing 12 of 138. All products under Cystoscope And Accessories, Flexible/Rigid
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.