Lumindex
LUMINDEX 3 (Dentmate-Plaque)
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical(Dongguan)Technology Company Limited | Dongguan | Guangdong | Contract manufacturer | 2 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
Record
| Listed by | Dentmate Technology Co., Ltd., Taiwan |
|---|---|
| FDA product code | HJN |
| Device type | Transilluminator, Battery-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1945 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-07-17 |
| Record revised | 2023-08-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LUMINDEX 3 | In distribution | |
| LUMINDEX 3 | In distribution | |
| LUMINDEX 3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 9 |
| NeoGlo® | Neotech Products, LLC | 9 |
| zumax | Zumax Medical Co., Ltd. | 4 |
| Bernell | Bernell | 3 |
| NeoGlo Disposable | Neotech Products, LLC | 2 |
| Amico Diagnostic Illuminator | Amico Diagnostic Incorporated | 2 |
| Venoscope | Venoscope, LLC | 2 |
| VF1000LED Vein locator | Fabinject Industria E Comercio Importacao E Exportacao Ltda | 1 |
| EZ-TRI-3600 | U.S. Ophthalmic, L.L.C. | 1 |
| Astodia | Stihler Electronic Gmbh | 1 |
| ESU Transilluminator | ESU Limited Liability Partnership | 1 |
| Wee Sight Transilluminator | International Biomedical, Ltd. | 1 |
Showing 12 of 15. All products under Transilluminator, 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.