MoleScope Lite
MoleScope™Lite is a handheld magnifier intended for examining intact skin, nail and hair by laypersons and healthcare professionals. Optionally, MoleScope™ Lite can be attached to a…
MoleScope™Lite is a handheld magnifier intended for examining intact skin, nail and hair by laypersons and healthcare professionals. Optionally, MoleScope™ Lite can be attached to a smartphone or tablet to capture digital images within the specifications of the mobile device.
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (4), Shanghai (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 11 |
| Nanjing Nikon Jiangnan Optical Instrument Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 4 |
| Evident GuangZhou Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 1 |
| Nanjing Jiangnan Novel Optics Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 1 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Shanghai Youding International Trade Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 17 |
| Shenzhen Margotan Tech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
Showing 12 of 19. All 19 manufacturers in China registered for Light, Microscope
Record
| Listed by | Metaoptima Technology Inc., Canada |
|---|---|
| FDA product code | IBJ |
| Device type | Light, Microscope |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3600 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-17 |
| Record revised | 2024-11-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 850147000094 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diagnostix™ | American Diagnostic Corp. | 95 |
| LW Scientific, Inc. | LW Scientific, Inc. | 26 |
| Henry Schein | Henry Schein, Inc. | 6 |
| Proscope™ Dermascope | American Diagnostic Corp. | 4 |
| Mikroscan | Mikroscan Technologies Inc | 3 |
| Seiler Medical Division | Seiler Instrument AND Manufacturing Company, Incorporated | 3 |
| VisionTek® | Sakura Finetek U.S.A., Inc. | 2 |
| NED-DP Nano Eye Device for Digital Pathology | NTP Nano Tech Projects SRL | 1 |
| NED-DH Nano Eye Device for Digital Hematology | NTP Nano Tech Projects SRL | 1 |
| Gynex | Gynex Corporation | 1 |
| Proscope™ | American Diagnostic Corp. | 1 |
| FotoFinder medicam | Fotofinder Systems Gmbh | 1 |
Showing 12 of 14. All products under Light, Microscope
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.