VorOtek M Scope
VorOtek M Scope - SpecFrame. Plate Magnification with Fully Integrated Surgical Quality Dimmable LED Illumination. Includes 2, 4 & 6 Dioptre Plate Magnifiers, Power Pack, Charger & Carry…
VorOtek M Scope – SpecFrame. Plate Magnification with Fully Integrated Surgical Quality Dimmable LED Illumination. Includes 2, 4 & 6 Dioptre Plate Magnifiers, Power Pack, Charger & Carry Case.
Who Else Makes It
Concentrated in Jiangsu (6), Henan (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Yuchang Optical Glasses Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 5 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Guilin Kevin Peter Technology Co., Ltd. | Guilin | Guangxi | Manufacturer | 13 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Chamfond Biotech Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 9 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
| Zhejiang Fude Medphotonic Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 4 |
Showing 12 of 13. All 13 manufacturers in China registered for Loupe, Binocular, Low Power
Record
| Listed by | Vorotek, Australia |
|---|---|
| FDA product code | HJH |
| Device type | Loupe, Binocular, Low Power |
| Device class | Class 1 |
| Regulation | 21 CFR 886.5120 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VSMH | In distribution | |
| VSMS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| zumax | Zumax Medical Co., Ltd. | 645 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 35 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 6 |
| VorOtek O Scope | Vorotek | 4 |
| VorOtek L Scope | Vorotek | 4 |
| HRP | Heine Optotechnik Gmbh & Co. KG. | 3 |
| Protective Lenses | Heine Optotechnik Gmbh & Co. KG. | 3 |
| HR | Heine Optotechnik Gmbh & Co. KG. | 3 |
| C 2.3 K | Heine Optotechnik Gmbh & Co. KG. | 2 |
| C 2.3 | Heine Optotechnik Gmbh & Co. KG. | 2 |
| Eclipse-146 | Quality Aspirators, Inc. | 1 |
| SuperVu XL Advantage 3.5x, at 42cm working distanc | Rudolf Riester Gmbh | 1 |
Showing 12 of 75. All products under Loupe, Binocular, Low Power
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.