M200 Series (Ceiling, Mobile)
RATING : AC 100-240 V, 50/60 Hz, 145-191 VA
6manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Huifeng Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| HI-Life Technology (Hebei) Co., Ltd. | Bazhou | Hebei | Manufacturer | 11 |
| Shenzhen Youmay Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Shanghai PAX Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
Record
| Listed by | Dentis Co., Ltd., South Korea |
|---|---|
| FDA product code | FTD |
| Device type | Lamp, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-12-27 |
| Record revised | 2021-05-26 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M200 | In distribution | |
| M200 | In distribution | |
| M210 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maquet PowerLED II | Maquet Gmbh | 1,930 |
| S300 Series | Dentis Co., Ltd. | 41 |
| Standop Volista® | Maquet Gmbh | 32 |
| L400 Series | Dentis Co., Ltd. | 24 |
| M400 Series (Ceiling, Mobile) | Dentis Co., Ltd. | 24 |
| Lamp, Surgical | Maquet Gmbh | 18 |
| Maquet Ezea | Maquet Gmbh | 18 |
| Maisilide | Shandong Deman Medical Equipment Group Co., Ltd. | 15 |
| S250 Series(Ceiling, Mobile) | Dentis Co., Ltd. | 11 |
| Lucea LED® | Maquet Gmbh | 7 |
| StarTrol | Huot Instruments, LLC | 7 |
| Rolite Volista Standop | Maquet Gmbh | 5 |
Showing 12 of 52. All products under Lamp, 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.