Comeg Medical Technologies
Light Source alone (without Box and accessories) "This 30 Watt LED light source has been especially designed for endoscopic diagnosis applications in medical practices of the following…
Light Source alone (without Box and accessories) “This 30 Watt LED light source has been especially designed for endoscopic diagnosis applications in medical practices of the following special fields: ent, gynecology, urology, veterinary. It is equipped with an electronic iris with fibre optic sensor, an automatic thermal protection system and a power level memory.”
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Dongguan Miqiang Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Shenzhen Yiguangnian Innovation Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 13 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Hunan Endoso Life Technology Co., Ltd. | Xiangtan | Hunan | Manufacturer | 7 |
| Shenzhen Sophway Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Sopro, France |
|---|---|
| FDA product code | NTN |
| Device type | Led Light Source |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K103813 |
| Record published | 2019-07-16 |
| Record revised | 2021-12-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PENTAX Medical USB Camera | In distribution | |
| SOPRO 281 LIGHT SOURCE | In distribution | |
| PENTAX Medical LED Light Source | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Led Light Source | Schölly Fiberoptic GmbH | 12 |
| Lucea LED® | Maquet Gmbh | 9 |
| Endolight | Richard Wolf Gmbh | 7 |
| ILO | ILO Electronic Gmbh | 7 |
| BR Surgical, LLC | BR Surgical LLC | 7 |
| Led Light Source | Karl Storz GmbH & Co. KG | 6 |
| Everlux Light Source | Ecleris SRL | 5 |
| eLUMA | ConMed Corporation | 5 |
| Led Light Source | Maquet Gmbh | 4 |
| Gimmi | Gimmi Gmbh | 4 |
| Comeg Medical | Sopro | 4 |
| Led Light Source | Richard Wolf Gmbh | 4 |
Showing 12 of 42. All products under Led Light Source
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103813 | 2011-03-22 |
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.