Enova Illumination
Micro Ergo Angled Prismatic 3.5x Oculars
15manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Guangxi (3), Shanghai (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 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
| Guangxi Ehall Medical Technology Co., Ltd. | Nanning | Guangxi | Manufacturer | 17 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
Showing 12 of 15. All 15 manufacturers in China registered for Loupe, Diagnostic/Surgical
Record
| Listed by | Enova Illumination, Inc, United States |
|---|---|
| FDA product code | FSP |
| Device type | Loupe, Diagnostic/Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-01-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 820002 | In distribution | |
| 99999-002 | In distribution | |
| 820005-001 | In distribution | |
| 820012-001 | In distribution | |
| 820003 | In distribution | |
| 820004 | In distribution | |
| 820009-001 | In distribution | |
| 80034-006 | In distribution | |
| 820001 | In distribution | |
| 820000 | In distribution | |
| 820013-001 | In distribution | |
| 820010-001 | In distribution | |
| 820007-001 | In distribution | |
| 820011-001 | In distribution | |
| 80034-008 | In distribution | |
| 820006-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eighteeth | Changzhou Sifary Medical Technology Co., Ltd. | 250 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 57 |
| Luxe™ 2.5 Semi-custom loupe | Metrex Research | 38 |
| Endeavour MD | Metrex Research | 12 |
| Spark TruColor | Metrex Research | 10 |
| Loupe Carrier | Sontec Instruments, Inc. | 5 |
| High Resolution Binocular Loupes SET | Sontec Instruments, Inc. | 5 |
| Diagnostix™ | American Diagnostic Corp. | 4 |
| XHL Xenon Halogen Bulb | Sontec Instruments, Inc. | 3 |
| LED Loupe Light | Sontec Instruments, Inc. | 3 |
| High Resolution Prismatic Binocular Loupes SET | Sontec Instruments, Inc. | 3 |
| High Resolution Binocular Loupe | Sontec Instruments, Inc. | 3 |
Showing 12 of 183. All products under Loupe, Diagnostic/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.