Lumax™ TS Pro
Lumax™ TS Pro Fiberoptic Cystometry System Sales Demo Unit
8manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Anhui (1), Hunan (1). 2 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 |
| Beijing Fanxing Guangdian Medical Treatment Equipment Co Ltd | Beijing | Beijing | Contract manufacturer | 5 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Hunan Vathin Medical Instrument Co., Ltd. | Xiangtan | Hunan | Manufacturer | 6 |
| Shenzhen Besdata Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Zhongshan Wesee Meditech Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 3 |
| Jiangsu Mole Electronic Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 2 |
Record
| Listed by | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | FEM |
| Device type | Accessories, Photographic, For Endoscope (Exclude Light Sources) |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K953734 |
| Record published | 2016-09-23 |
| Record revised | 2024-02-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TSBAS-SRD | In distribution | |
| EMG1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Olympus | Keymed (Medical & Industrial Equipment) Ltd | 39 |
| Fusion Design | Richard Wolf Gmbh | 18 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | Richard Wolf Gmbh | 17 |
| Riwo | Richard Wolf Gmbh | 9 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | Medos International Sàrl | 7 |
| ScopEYE | MediThinQ Co., Ltd. | 4 |
| Pentax | Hoya Corporation | 3 |
| Gimmi | Gimmi Gmbh | 3 |
| Video Camera Insert | Boston Scientific Corporation | 3 |
| Fusion | Richard Wolf Gmbh | 3 |
| Zeos | Santa Barbara Imaging Systems | 2 |
| Fujifilm | Fujifilm Corporation | 2 |
Showing 12 of 56. All products under Accessories, Photographic, For Endoscope (Exclude Light Sources)
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.