Bernell
Handheld TBI: Version 2.0 (PD 65mm)
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 | Bernell |
|---|---|
| FDA product code | HJN |
| Device type | Transilluminator, Battery-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1945 |
| Premarket notification | Exempt |
| Record published | 2026-05-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MTBIFL | In distribution | |
| BERAI | In distribution | |
| MTBIH2 | 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 |
| Lumindex | Dentmate Technology Co., Ltd. | 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.