Endoscopic Video Imaging System/Component, Gastroenterology-Urology
NIR FI+ Camera Head Full 4K UHD
8manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Shenzhen Sophway Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Schölly Fiberoptic GmbH |
|---|---|
| FDA product code | FET |
| Device type | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Record published | 2025-06-11 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Hydrogen Peroxide |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 70 °C; Storage environment humidity 5 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 95-3909 | In distribution | |
| 95-3981 | In distribution | |
| SC-7000X | In distribution | |
| 95-3908 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endocam | Richard Wolf Gmbh | 21 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Karl Storz GmbH & Co. KG | 20 |
| Gimmi | Gimmi Gmbh | 9 |
| Image 1 | Karl Storz GmbH & Co. KG | 8 |
| Exalt™ | Boston Scientific Corporation | 8 |
| Conmed | ConMed Corporation | 7 |
| Video Adapter | Olympus Medical Systems Corp. | 6 |
| EleVision™ | Schölly Fiberoptic GmbH | 6 |
| Evis Exera Colonovideoscope | Olympus Medical Systems Corp. | 5 |
| Water Resistant CAP | Olympus Medical Systems Corp. | 5 |
| CystoView™ | Verathon Medical (Canada) ULC | 5 |
| Riwo | Richard Wolf Gmbh | 5 |
Showing 12 of 105. All products under Endoscopic Video Imaging System/Component, Gastroenterology-Urology
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.