Fujifilm
This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
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 | Fujifilm Corporation, Japan |
|---|---|
| FDA product code | FEM |
| Device type | Accessories, Photographic, For Endoscope (Exclude Light Sources) |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-07 |
| Record revised | 2024-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 85 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CP-1TB | In distribution | |
| CP-1 | 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 |
| Endocraft LLC | Endocraft LLC. | 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.