SemiFlex Scope
55 centimeter limited use endoscope for urological application.
21manufacturers in China registered for this device type
33catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (3), Shanghai (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Ningbo Wise Optomech Technology Corporation | Ningbo | Zhejiang | Contract manufacturer | 4 |
| 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 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Hunan Endoso Life Technology Co., Ltd. | Xiangtan | Hunan | Manufacturer | 7 |
Showing 12 of 21. All 21 manufacturers in China registered for Ureteroscope And Accessories, Flexible/Rigid
Record
| Listed by | Maxiflex, LLC |
|---|---|
| FDA product code | FGB |
| Device type | Ureteroscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K111480 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Sizes | Catheter gauge 9.5 Fr; length 45 to 65 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MF-ENDO 45 E | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 55 A1 | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 55 LU | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 60 | Length 60 cm | In distribution |
| MF-ENDO 55 | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 60 A1 | Length 60 cm | In distribution |
| MF-ENDO 65 E A1 | Length 65 cm | In distribution |
| MF-ENDO 60 LU | Length 60 cm | In distribution |
| MF-ENDO 65 E | Length 65 cm | In distribution |
| MF-ENDO 45 LU A1 | Length 45 cm | In distribution |
| MF-ENDO 55 E A1 | Length 55 cm | In distribution |
| MF-ENDO 65 LU E A2 | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 60 LU E A1 | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 65 A1 | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 45 LU E A1 | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 45 A1 | Length 45 cm | In distribution |
| MF-ENDO 65 LU A1 | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 55 LU A1 | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 55 E | Length 55 cm | In distribution |
| MF-ENDO 60 LU A1 | Length 60 cm | In distribution |
| MF-ENDO 65 LU E | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 45 LU E | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 45 E A1 | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 55 LU E | Length 55 cm | In distribution |
| MF-ENDO 60 E A1 | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 45 LU | Length 45 cm | In distribution |
| MF-ENDO 65 LU | Length 65 cm | In distribution |
| MF-ENDO 65 | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 55 LU E A1 | Length 55 cm | In distribution |
| MF-ENDO 65 LU E A1 | Length 65 cm | In distribution |
| MF-ENDO 60 LU E | Catheter Gauge 9.5 Fr | In distribution |
| MF-ENDO 45 | Length 45 cm | In distribution |
| MF-ENDO 60 E | Catheter Gauge 9.5 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ureteroscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 36 |
| E-Line | Richard Wolf Gmbh | 28 |
| Olympus | Olympus Winter & IBE Gmbh | 28 |
| Uscope | Zhuhai Pusen Medical Technology Co., Ltd. | 23 |
| WiScope® | OTU Medical Inc | 16 |
| Redpine | Guangzhou RED Pine Medical Instrument Co., Ltd. | 16 |
| LithoVue | Boston Scientific Corporation | 15 |
| Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 14 |
| Dornier MedTech | Dornier Medtech America, Inc. | 12 |
| Innovex | Shanghai AnQing Medical Instrument Co., Ltd. | 12 |
| Single Use Video Ureteroscope Direct In-Scope Suction | Zhuhai Pusen Medical Technology Co., Ltd. | 12 |
| Ascend™ Single-Use Flexible Ureteroscope | Guangzhou RED Pine Medical Instrument Co., Ltd. | 12 |
Showing 12 of 75. All products under Ureteroscope 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.