Pentax
Carrying Case For VNL-ST VE-B11
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Heearly Technology Co., Ltd. | Bao An District, Shenzhen | Guangdong | Contract manufacturer | 13 |
Record
| Listed by | Hoya Corporation, Bulgaria |
|---|---|
| FDA product code | EQL |
| Device type | Laryngostroboscope |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4750 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-07-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VE-B11 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jedmed | Jedmed Instrument Company | 62 |
| Laryngostroboscope | Pentax of America, Inc. | 22 |
| Laryngostroboscope | Karl Storz GmbH & Co. KG | 7 |
| Video Laryngostroboscope | Pentax of America, Inc. | 3 |
| Olympus | Olympus Winter & IBE Gmbh | 3 |
| Rigid Scopes | Pentax of America, Inc. | 3 |
| Pulsar | Karl Storz GmbH & Co. KG | 2 |
| Atmos | Atmos Medizintechnik Gmbh & Co. KG | 2 |
| Optomic | Optomic España SA | 2 |
| Pentax Medical Rigid Laryngostroboscopes | Pentax of America, Inc. | 1 |
| Pentax Medical Laryngeal Stroboscope | Pentax of America, Inc. | 1 |
| Machida | Machida Endoscope Co., Ltd. | 1 |
Showing 12 of 14. All products under Laryngostroboscope
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.