Remex KA6
Catalogue number REMEX KA6, listed by Remedi Inc., South Korea, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (2), Beijing (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Zhuhai Dipu Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 3 |
Record
| Listed by | Remedi Inc., South Korea |
|---|---|
| FDA product code | IZI |
| Device type | System, X-Ray, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1600 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K212144 |
| Record published | 2022-04-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 76 to 106 KiloPascal; Handling environment humidity 5 to 85 % RH; Handling environment temperature 15 to 40 °C; Storage environment atmospheric pressure 76 to 106 KiloPascal; Storage environment humidity 5 to 95 % RH; Storage environment temperature -40 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REMEX KA6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterimed | Sterimed, Inc. | 114 |
| Med-Syringe | Argon Medical Devices, Inc. | 16 |
| Control Syringe | Argon Medical Devices, Inc. | 14 |
| Novadaq and Pinpoint | Novadaq Technologies, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 12 |
| Namic | Navilyst Medical, Inc. | 9 |
| Namic | Medline Industries, Inc. | 8 |
| iMRX System | Imris Imaging, Inc. | 6 |
| System, X-Ray, Angiographic | B. Braun Medical Inc. | 4 |
| System, X-Ray, Angiographic | Intuitive Surgical, Inc. | 3 |
| Leica FL800 | Leica Microsystems (Schweiz) AG | 3 |
| Infrared 800 with Flow® 800 Option | Carl Zeiss Meditec Inc | 2 |
Showing 12 of 51. All products under System, X-Ray, Angiographic
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.