Cystoscopy Sheath
42 catalogue numbers from 196 020 301, 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 | 2018-03-20 |
| Record revised | 2019-03-11 (version 5) |
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 |
|---|---|---|
| 196 020 301 | In distribution | |
| 196 080 200 | In distribution | |
| 196 810 101 | In distribution | |
| 198 020 200BC | In distribution | |
| 196 080 000 | In distribution | |
| 196 020 100 | In distribution | |
| 198 020 400 | In distribution | |
| 198 020 100BC | In distribution | |
| 196 810 101BC | In distribution | |
| 198 020 400BC | In distribution | |
| 196 080 400 | In distribution | |
| 196 800 100BC | In distribution | |
| 196 020 500 | In distribution | |
| 196 800 100 | In distribution | |
| 198 020 100 | In distribution | |
| 196 080 200BC | In distribution | |
| 196 020 200BC | In distribution | |
| 196 020 200 | In distribution | |
| 196 020 301BC | In distribution | |
| 198 020 200 | In distribution | |
| 196 020 400 | In distribution | |
| 196 080 300 | In distribution | |
| 196 080 410BC | In distribution | |
| 196 080 310 | In distribution | |
| 196 080 210 | In distribution | |
| 198 020 300 | In distribution | |
| 196 020 400BC | In distribution | |
| 196 080 100BC | In distribution | |
| 196 080 400BC | In distribution | |
| 196 080 410 | In distribution | |
| 196 080 300BC | In distribution | |
| 196 080 310BC | In distribution | |
| 196 020 100BC | In distribution | |
| 196 020 500BC | In distribution | |
| 198 020 500 | In distribution | |
| 196 020 300 | In distribution | |
| 198 020 500BC | In distribution | |
| 196 080 210BC | In distribution | |
| 198 020 300BC | In distribution | |
| 196 080 100 | In distribution | |
| 196 020 300BC | In distribution | |
| 196 080 000BC | 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 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 |
| 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.