Diagnostix™
Diagnostix Portable Dermascope,3.5v, LED, Euro
15manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Guangxi (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
| Guangxi Ehall Medical Technology Co., Ltd. | Nanning | Guangxi | Manufacturer | 17 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
Showing 12 of 15. All 15 manufacturers in China registered for Loupe, Diagnostic/Surgical
Record
| Listed by | American Diagnostic Corp., United States |
|---|---|
| FDA product code | FSP |
| Device type | Loupe, Diagnostic/Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature 14 to 131 °F |
| Packaging | Master case of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5450 | In distribution | ||
| 5413-EU | 10 | In distribution | |
| 5413 | In distribution | ||
| 54313 | Finger Thickness.31 to.79 inches. | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eighteeth | Changzhou Sifary Medical Technology Co., Ltd. | 250 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 57 |
| Luxe™ 2.5 Semi-custom loupe | Metrex Research | 38 |
| Enova Illumination | Enova Illumination, Inc | 16 |
| Endeavour MD | Metrex Research | 12 |
| Spark TruColor | Metrex Research | 10 |
| Loupe Carrier | Sontec Instruments, Inc. | 5 |
| High Resolution Binocular Loupes SET | Sontec Instruments, Inc. | 5 |
| XHL Xenon Halogen Bulb | Sontec Instruments, Inc. | 3 |
| LED Loupe Light | Sontec Instruments, Inc. | 3 |
| High Resolution Prismatic Binocular Loupes SET | Sontec Instruments, Inc. | 3 |
| High Resolution Binocular Loupe | Sontec Instruments, Inc. | 3 |
Showing 12 of 183. All products under Loupe, Diagnostic/Surgical
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.