MedLED Spectra
MG3/6/8 Includes 3 Bezels Headlamp Assembly, Carrying Case
4manufacturers in China registered for this device type
27catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Nanjing Yanan Special Lighting Factory | Nanjing | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Riverpoint Medical LLC, United States |
|---|---|
| FDA product code | HPP |
| Device type | Headlamp, Operating, Battery-Operated |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4335 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Packaging | Pack of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MG8-HK | In distribution | |
| MG3-HK | In distribution | |
| M-90116 | In distribution | |
| M-90007 | In distribution | |
| MG368-SK | In distribution | |
| MG6-HK | In distribution | |
| M-92461 | In distribution | |
| M-92401 | In distribution | |
| M-90211 | In distribution | |
| M-90155 | In distribution | |
| M-92401-ES | In distribution | |
| MG6-SK | In distribution | |
| M-92431 | In distribution | |
| M-90212 | In distribution | |
| M-90156 | In distribution | |
| MG8-ES | In distribution | |
| M-91405 | In distribution | |
| M-90006 | In distribution | |
| MG368-D | In distribution | |
| MG8-SK | In distribution | |
| M-92481 | In distribution | |
| M-90910 | In distribution | |
| M-90205 | In distribution | |
| M-90206 | In distribution | |
| MG3-SK | In distribution | |
| M-90110 | In distribution | |
| MG368-HK | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Enova Illumination | Enova Illumination, Inc | 79 |
| MedLED Chrome | Riverpoint Medical LLC | 41 |
| Jedmed | Jedmed Instrument Company | 28 |
| Power Dental USA | Power Dental U.S.A. Inc. | 26 |
| MedLED | Riverpoint Medical LLC | 19 |
| Quasar | Enova Illumination, Inc | 12 |
| Qosmic | Enova Illumination, Inc | 11 |
| BR Surgical, LLC | BR Surgical LLC | 10 |
| Quantum | Enova Illumination, Inc | 10 |
| MaxLite Elite | Riverpoint Medical LLC | 10 |
| Headlamp, Operating, Battery-Operated | Enova Illumination, Inc | 8 |
| MedLED Face Shield | Riverpoint Medical LLC | 8 |
Showing 12 of 68. All products under Headlamp, Operating, Battery-Operated
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.