Isolite, I2
Power Adaptor, 5VDC-1Amp, Grey
16manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (8), Zhejiang (2), Jiangsu (1). 3 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 |
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| Forefront (Xiamen) Medical Devices Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
Showing 12 of 16. All 16 manufacturers in China registered for Light, Operating, Dental
Record
| Listed by | Zyris, Inc., United States |
|---|---|
| FDA product code | EAZ |
| Device type | Light, Operating, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4630 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-04-19 |
| Record revised | 2024-04-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PIL0205 | In distribution | |
| EIL0204 | In distribution | |
| PIL0203 | In distribution | |
| PIL0204 | In distribution | |
| PIL0202 | In distribution | |
| PIL0211 | In distribution | |
| EIL0205 | In distribution | |
| PIL0201 | In distribution | |
| PIL0207 | In distribution | |
| EIL0201 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midmark | Midmark Corporation | 152 |
| Forest | Ls Enterprises, Inc. | 93 |
| DCI Edge | DCI International, LLC | 57 |
| Dentalez | Dentalez Alabama, Inc. | 25 |
| A-dec | A-dec, Inc. | 23 |
| Faro | F.a.r.o. Fabbrica Apparecchiature Razionali Odontoiatriche SPA | 21 |
| Bel-Nova LED | Takara Belmont Corporation | 11 |
| Bel-Halo LED | Takara Belmont Corporation | 10 |
| Bel-Halo Dental Light | Takara Belmont Corporation | 10 |
| Dental Operating Light | Medfruition Electronics Technology Co., Ltd. | 10 |
| JMU | JMU Dental, Inc | 9 |
| Clesta LED Dental Light | Takara Belmont Corporation | 9 |
Showing 12 of 42. All products under Light, Operating, Dental
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.