Hopkins
HOPKINS® Lateral Telescope 70°,1.9/2.1mm
16manufacturers in China registered for this device type
50catalogue 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 | Karl Storz GmbH & Co. KG |
|---|---|
| FDA product code | FAJ |
| Device type | Cystoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Record published | 2016-09-23 |
| Record revised | 2024-10-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Hydrogen Peroxide, Moist Heat or Steam Sterilization, Ethylene Oxide |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 24941BAL | In distribution | |
| 26075N | In distribution | |
| 27020FA | In distribution | |
| 27020BA | In distribution | |
| 27017BA | In distribution | |
| 28116CA | In distribution | |
| 26105FA | In distribution | |
| 27095AA | In distribution | |
| 24954BA | In distribution | |
| 27018AA | In distribution | |
| 27018BA | In distribution | |
| 26020FA | In distribution | |
| 27017CA | In distribution | |
| 50230BA | In distribution | |
| 50230BWA | In distribution | |
| 27325BA | In distribution | |
| 27035BA | In distribution | |
| 27093AA | In distribution | |
| 12067VA | In distribution | |
| 58700BA | In distribution | |
| 27005CA | In distribution | |
| 27324AA | In distribution | |
| 58705AA | In distribution | |
| 24941BA | In distribution | |
| 27035BB | In distribution | |
| 26092AMA | In distribution | |
| 27301AA | In distribution | |
| 27005FA | In distribution | |
| 27005EA | In distribution | |
| 26120AA | In distribution | |
| 27301BA | In distribution | |
| 58705BA | In distribution | |
| 26008BA | In distribution | |
| 27029AA | In distribution | |
| 27018CA | In distribution | |
| 27292AMA | In distribution | |
| 26035FA | In distribution | |
| 27017AA | In distribution | |
| 27023ABA | In distribution | |
| 27294AA | In distribution | |
| 27020CA | In distribution | |
| 24995BA | In distribution | |
| 27005AA | In distribution | |
| 27092AMA | In distribution | |
| 27005BGA | In distribution | |
| 27005BA | In distribution | |
| 27020AA | In distribution | |
| 26105BA | In distribution | |
| 27293AA | In distribution | |
| 27295AA | 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 |
| 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 |
| 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
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Karl Storz Endoscopy-America, Inc. | UDI-DI | 2024-07-23 | Class II | Process design | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | 425 units |
| Karl Storz Endoscopy-America, Inc. | UDI-DI | 2024-07-23 | Class II | Process design | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | 34 units |
| Karl Storz Endoscopy-America, Inc. | UDI-DI | 2024-07-23 | Class II | Process design | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | 1982 units |
| Karl Storz Endoscopy-America, Inc. | UDI-DI | 2024-07-23 | Class II | Process design | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | 109 UNITS |
| Karl Storz Endoscopy-America, Inc. | UDI-DI | 2024-07-23 | Class II | Process design | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | 78 units |
| Karl Storz Endoscopy-America, Inc. | UDI-DI | 2024-07-23 | Class II | Process design | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | 59 UNITS |
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.