Lumio UV
Large-area handheld UV exam light (UV light)
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 | DermLite LLC, United States |
|---|---|
| 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 | 2024-06-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LUM-UV | 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 |
| MoleScope II | Metaoptima Technology Inc. | 10 |
| 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 |
Showing 12 of 309. All products under Light, Examination, Medical, Battery Powered
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-03-20 | Class II | Error in labeling | Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling. | 32 units |
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.