Hubble Digital Vision
Battery powered electronic magnification loupe and display system for use in clinical settings.
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Guangxi (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Guilin Kevin Peter Technology Co., Ltd. | Guilin | Guangxi | Manufacturer | 13 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | CAO Group, Inc., United States |
|---|---|
| FDA product code | EPT |
| Device type | Microscope, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-01-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 005-00109 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jedmed | Jedmed Instrument Company | 144 |
| Seiler Medical Division | Seiler Instrument AND Manufacturing Company, Incorporated | 87 |
| Microscope | Ecleris SRL | 58 |
| M320 Optics Carrier | Leica Microsystems (Schweiz) AG | 11 |
| Microscope, Surgical | Karl Storz GmbH & Co. KG | 10 |
| BR Surgical, LLC | BR Surgical LLC | 8 |
| Vitom | Karl Storz GmbH & Co. KG | 8 |
| Quintus | Karl Storz GmbH & Co. KG | 7 |
| Extaro 300 | Carl Zeiss Meditec (Suzhou) Co., Ltd. | 6 |
| G-Series 3-STEP Microscope With 120 Degree Angled Coupler, AND Dental Composite | Global Surgical Corp. | 5 |
| G-Series 4-STEP Microscope With 120 Degree Angled Counterbalance Coupler, White | Global Surgical Corp. | 4 |
| Microcast | Karl Storz GmbH & Co. KG | 4 |
Showing 12 of 290. All products under Microscope, Surgical
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.