AED Endopro® Primo Series Camera
2 catalogue numbers from EP2050HD, listed by National Advanced Endoscopy Devices, Inc., United States, under Camera, Television, Endoscopic, Without Audio. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Anhui (2), Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Hunan Endoso Life Technology Co., Ltd. | Xiangtan | Hunan | Manufacturer | 7 |
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
Record
| Listed by | National Advanced Endoscopy Devices, Inc., United States |
|---|---|
| FDA product code | FWF |
| Device type | Camera, Television, Endoscopic, Without Audio |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-09 |
| Record revised | 2025-09-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2025-09-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EP2050HD | In distribution | |
| EP2050HD | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Camera, Television, Endoscopic, Without Audio | Smith & Nephew, Inc. | 30 |
| C-Camsource® | Joimax Gmbh | 10 |
| Hayden Medical | Hayden Medical Inc | 7 |
| Fibre optic cable adpater | Joimax Gmbh | 6 |
| Camsource® | Joimax Gmbh | 6 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 5 |
| Camera, Television, Endoscopic, Without Audio | Pentax of America, Inc. | 4 |
| D-Camsource® | Joimax Gmbh | 4 |
| Gimmi | Gimmi Gmbh | 4 |
| Camera, Television, Endoscopic, Without Audio | Karl Storz GmbH & Co. KG | 3 |
| Camera, Television, Endoscopic, Without Audio | Medos International Sàrl | 3 |
| Camera, Television, Endoscopic, Without Audio | Schölly Fiberoptic GmbH | 3 |
Showing 12 of 33. All products under Camera, Television, Endoscopic, Without Audio
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.