MoleScope II
MoleScope is a battery-powered dermatoscope intended to be attached to smartphones and tablets to take images of skin, scalp, hair, nail, and other body surfaces with high magnification and…
MoleScope is a battery-powered dermatoscope intended to be attached to smartphones and tablets to take images of skin, scalp, hair, nail, and other body surfaces with high magnification and cross-polarized light. It is a reusable, non-invasive device for imaging and documentation only.
Who Else Makes It
Concentrated in Zhejiang (22), Jiangsu (14), Guangdong (7). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Aosi Healthcare Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 18 |
| Wenzhou Kangju Medical Instrument Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 15 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
Showing 12 of 53. All 53 manufacturers in China registered for Light, Examination, Medical, Battery Powered
Record
| Listed by | Metaoptima Technology Inc., Canada |
|---|---|
| FDA product code | KYT |
| Device type | Light, Examination, Medical, Battery Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6350 |
| 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, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 627843751328 | In distribution | |
| 850147000018 | In distribution | |
| 850147000087 | In distribution | |
| 850147000063 | In distribution | |
| 850147000070 | In distribution | |
| 627843751397 | In distribution | |
| 850147000049 | In distribution | |
| 627843751403 | In distribution | |
| 627843751342 | In distribution | |
| 627843751380 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Penlight | Rashman Corp. | 58 |
| Adlite™ Plus | American Diagnostic Corp. | 20 |
| Metalite™ | American Diagnostic Corp. | 11 |
| Metalite™ II | American Diagnostic Corp. | 10 |
| Firefly | Firefly Global | 9 |
| SurgiTel | Surgitel | 7 |
| PeriOptix | DEN-MAT Holdings, LLC | 6 |
| Dr. Vampa | Dr Vampa S.R.L. | 5 |
| Adlite™ II | American Diagnostic Corp. | 5 |
| Emsrun | Wuxi Emsrun Technology Co., Ltd. | 4 |
| MDF® | MDF Instruments Medifriend Inc. | 4 |
| Portaled | Ecleris SRL | 4 |
Showing 12 of 309. All products under Light, Examination, Medical, Battery Powered
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.