E-Line
URETERORENOSCOPE 5° 6.5/8.5FR WL 330MM semi-rigid, with straight ocular lens, working channel 1: 1x4 (2x2.2)Fr, working channel 2: 2.4Fr, atraumatic distal tip, TL 473mm, fiber image…
URETERORENOSCOPE 5° 6.5/8.5FR WL 330MM semi-rigid, with straight ocular lens, working channel 1: 1×4 (2×2.2)Fr, working channel 2: 2.4Fr, atraumatic distal tip, TL 473mm, fiber image carrier, reusable
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 | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | FGB |
| Device type | Ureteroscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2024-11-21 (version 8) |
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 |
| Sizes | Length 120 to 430 mm; angle 5 to 12 ° |
| Distribution end date | 2024-01-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8703518 | Length 430 mm | In distribution |
| 8703524 | Angle 12 ° | In distribution |
| 8703534 | Length 430 mm | In distribution |
| 8702534 | Length 430 mm | In distribution |
| 8702518 | Length 430 mm | In distribution |
| 8702524 | Length 430 mm | In distribution |
| 8701518 | Angle 5 ° | In distribution |
| 8708518 | Length 430 mm | In distribution |
| 8702517 | Length 330 mm | In distribution |
| 8701534 | Angle 5 ° | In distribution |
| 8701517 | Angle 5 ° | In distribution |
| 8703517 | Length 330 mm | In distribution |
| 8708534 | Length 430 mm | In distribution |
| 8708517 | Length 330 mm | In distribution |
| 8702261 | In distribution | |
| 8704524 | Angle 12 ° | In distribution |
| 8715401 | Angle 5 ° | In distribution |
| 8703514 | Length 430 mm | Withdrawn |
| 8702251 | Withdrawn | |
| 8704523 | Length 315 mm | Withdrawn |
| 8702523 | Angle 5 ° | Withdrawn |
| 8703533 | Angle 12 ° | Withdrawn |
| 8701533 | Angle 5 ° | Withdrawn |
| 8702514 | Length 430 mm | Withdrawn |
| 8702513 | Length 330 mm | Withdrawn |
| 8702533 | Length 315 mm | Withdrawn |
| 8703523 | Length 315 mm | Withdrawn |
| 8708533 | Angle 5 ° | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ureteroscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 36 |
| SemiFlex Scope | Maxiflex, LLC | 33 |
| 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.