AED 35MM Optical Coupler
Catalogue number CPL 35, listed by National Advanced Endoscopy Devices, Inc., United States, under Accessories, Photographic, For Endoscope (Exclude Light Sources). 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
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 | National Advanced Endoscopy Devices, Inc., United States |
|---|---|
| FDA product code | FEM |
| Device type | Accessories, Photographic, For Endoscope (Exclude Light Sources) |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-03-06 |
| Record revised | 2021-03-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Ethylene Oxide |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CPL 35 | 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 |
| Fujifilm | Fujifilm Corporation | 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.