Cystoscopy Instrument
42 catalogue numbers from 395 400 007BC, 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
42catalogue 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 | 2016-12-22 |
| Record revised | 2019-08-21 (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 |
|---|---|---|
| 395 400 007BC | In distribution | |
| 395 400 104 | In distribution | |
| 395 800 001 | In distribution | |
| 395 400 021 | In distribution | |
| 395 400 035 | In distribution | |
| 395 400 020 | In distribution | |
| 395 400 002 | In distribution | |
| 395 400 115 | In distribution | |
| 395 400 107 | In distribution | |
| 395 400 008BC | In distribution | |
| 395 400 005 | In distribution | |
| 398 400 008 | In distribution | |
| 395 400 007 | In distribution | |
| 398 400 030 | In distribution | |
| 395 400 008 | In distribution | |
| 398 400 008BC | In distribution | |
| 395 400 022 | In distribution | |
| 395 400 113 | In distribution | |
| 395 400 003 | In distribution | |
| 395 400 116 | In distribution | |
| 395 400 030 | In distribution | |
| 395 400 030BC | In distribution | |
| 395 700 010 | In distribution | |
| 395 700 000 | In distribution | |
| 398 400 035BC | In distribution | |
| 398 400 030BC | In distribution | |
| 395 400 004 | In distribution | |
| 395 400 106 | In distribution | |
| 398 400 031BC | In distribution | |
| 398 400 035 | In distribution | |
| 395 800 002 | In distribution | |
| 395 400 000 | In distribution | |
| 395 400 114 | In distribution | |
| 395 400 035BC | In distribution | |
| 395 700 030 | In distribution | |
| 395 400 001 | In distribution | |
| 395 400 102 | In distribution | |
| 395 400 117 | In distribution | |
| 395 400 105 | In distribution | |
| 395 400 103 | In distribution | |
| 395 700 020 | In distribution | |
| 398 400 031 | 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 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 |
| Cystoscope | Sopro-Comeg GmbH | 28 |
| 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.