Comeg Medical
This camera is a 1CCD color camera, 100% digital, with deported electronic.
46manufacturers in China registered for this device type
16catalogue numbers in this listing
13510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (15), Jiangsu (13), Zhejiang (7). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Shenzhen Jingxintai Houseware Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| MediConcepts Technology (Shenzhen) Company Limited | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Comhuge Medical Wire AND Harness Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
Showing 12 of 46. All 46 manufacturers in China registered for Laparoscope, General & Plastic Surgery
Record
| Listed by | Sopro, France |
|---|---|
| FDA product code | GCJ |
| Device type | Laparoscope, General & Plastic Surgery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K082796 |
| Record published | 2016-09-24 |
| Record revised | 2021-12-22 (version 4) |
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 |
|---|---|---|
| S218 SOPRO US WOLF | In distribution | |
| SOPRO 184 CAPTEUR 90° NTSC F12 | In distribution | |
| SOPRO 184 CAPTEUR NTSC | In distribution | |
| S218 SOPRO US OLYMPUS | In distribution | |
| S230 SOPRO US OLYMPUS | In distribution | |
| S230 SOPRO US WOLF | In distribution | |
| S184 CCU SOPRO SDI US | In distribution | |
| S184 CCU SOPRO SDI (Only) | In distribution | |
| SOPRO 218 – SOURCE DE LUMIERE XENON 180W – SOPRO – US | In distribution | |
| SOPRO 184 CAPTEUR 90° NTSC F15 | In distribution | |
| S184 CCU SOPRO US | In distribution | |
| S184 CCU SOPRO US | In distribution | |
| S184 CCU SOPRO US | In distribution | |
| SOPRO 230 – SOURCE DE LUMIERE XENON 300W – SOPRO | In distribution | |
| S218 SOPRO US OLYMPUS | In distribution | |
| S184 CCU SOPRO SDI US | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed | Elmed, Inc. | 3,796 |
| Surgical Direct | Surgical Direct, Inc. | 2,319 |
| Novo Surgical | Novo Surgical, Inc. | 1,320 |
| Elmed Incorporated | Elmed, Inc. | 911 |
| Laparoscope, General & Plastic Surgery | Karl Storz GmbH & Co. KG | 774 |
| Snowden-Pencer | Steris Corporation | 693 |
| Millennium | Avalign Technologies, Inc. | 683 |
| Hermann Medizintechnik GmbH | Hermann Medizintechnik Gmbh | 615 |
| Clickline | Karl Storz GmbH & Co. KG | 582 |
| V. Mueller | Carefusion 2200, Inc. | 553 |
| Grasping forceps | Sopro-Comeg GmbH | 462 |
| Gimmi | Gimmi Gmbh | 387 |
Showing 12 of 1,584. All products under Laparoscope, General & Plastic Surgery
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K082796 | 2009-04-01 |
| K072912 | 2007-11-16 |
| K070102 | 2007-02-20 |
| K031593 | 2003-09-16 |
| K020915 | 2002-06-14 |
| K020270 | 2002-03-14 |
| K013090 | 2001-12-13 |
| K000424 | 2000-03-31 |
| K000423 | 2000-03-31 |
| K000422 | 2000-03-31 |
| K973795 | 1998-01-02 |
| K973794 | 1998-01-02 |
| K973796 | 1998-01-02 |
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.