JMU
JMU Dental Intraoral Camera, 720P (1280x720 pixels), detachable, 8.2’/2.5m cable with metal connector
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Hunan (1), Zhejiang (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Tonglu Youshi Medical Instrument Co., Ltd. | Tonglu | Zhejiang | Manufacturer | 10 |
| Dongguan Magenta Medical Equipment Co., Ltd. | Dongguan | Guangdong | Manufacturer | 6 |
Record
| Listed by | JMU Dental, Inc, United States |
|---|---|
| FDA product code | FTS |
| Device type | Camera, Cine, Endoscopic, With Audio |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2025-05-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 22919002 | In distribution | |
| 22919002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Telecam | Karl Storz GmbH & Co. KG | 2 |
| Intraoral Camera | Denjoy Dental Co., Ltd. | 1 |
| Camera, Cine, Endoscopic, With Audio | Karl Storz GmbH & Co. KG | 1 |
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.