MedLED Chrome
GOV - MC3 MC3 HT Hosp Kit Incl Headlamp Assembly, Carry Case
4manufacturers in China registered for this device type
41catalogue 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 | 2023-10-25 |
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 |
|---|---|---|
| M-92301 | In distribution | |
| M-90201 | In distribution | |
| M-91307 | In distribution | |
| MC7-ST-SK | In distribution | |
| MC7-ST-HK | In distribution | |
| MC6-ST-SK-GOV | In distribution | |
| M-90909 | In distribution | |
| MC367-HT-SK | In distribution | |
| M-90151 | In distribution | |
| M-90004 | In distribution | |
| MC7-HT-HK | In distribution | |
| MC3-HT-SK | In distribution | |
| M-90921 | In distribution | |
| MC3-HT-SK-GOV | In distribution | |
| M-92361 | In distribution | |
| MC3-HT-HK | In distribution | |
| MC7-HT-SK-GOV | In distribution | |
| M-91305 | In distribution | |
| M-90611 | In distribution | |
| M-91310 | In distribution | |
| MC3-HT-HK-GOV | In distribution | |
| M-90612 | In distribution | |
| MC6-ST-HK | In distribution | |
| MC6-ST-SK-R | In distribution | |
| M-90202 | In distribution | |
| MC6-HT-HK | In distribution | |
| MC6-HT-HK-GOV | In distribution | |
| MC3-ST-SK | In distribution | |
| M-91308 | In distribution | |
| MC6-ST-SK | In distribution | |
| MC6-HT-SK-GOV | In distribution | |
| M-92371 | In distribution | |
| MC3-ST-HK | In distribution | |
| MC7-HT-HK-GOV | In distribution | |
| M-92302 | In distribution | |
| MC367-D | In distribution | |
| MC7-ST-HK-GOV | In distribution | |
| M-92331 | In distribution | |
| M-91306 | In distribution | |
| MC7-HT-SK | In distribution | |
| M-90908 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Enova Illumination | Enova Illumination, Inc | 79 |
| Jedmed | Jedmed Instrument Company | 28 |
| MedLED Spectra | Riverpoint Medical LLC | 27 |
| 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.