SurgiTel
Suplimentary light source for surgical and dental procedures.
53manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (22), Jiangsu (14), Guangdong (7). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Aosi Healthcare Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 18 |
| Wenzhou Kangju Medical Instrument Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 15 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
Showing 12 of 53. All 53 manufacturers in China registered for Light, Examination, Medical, Battery Powered
Record
| Listed by | Surgitel |
|---|---|
| FDA product code | KYT |
| Device type | Light, Examination, Medical, Battery Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6350 |
| Premarket notification | Exempt |
| Record published | 2023-01-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Wireless LED Headlight | In distribution | |
| Micro LED Headlight | In distribution | |
| Surgical Headband 2.0 LED | In distribution | |
| Eclipse CS LED Headlight | In distribution | |
| Surgical 2.0 LED Headlight | In distribution | |
| Wireless Air LED Headlight | In distribution | |
| Mini HI LED Headlight | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Penlight | Rashman Corp. | 58 |
| Adlite™ Plus | American Diagnostic Corp. | 20 |
| Metalite™ | American Diagnostic Corp. | 11 |
| MoleScope II | Metaoptima Technology Inc. | 10 |
| Metalite™ II | American Diagnostic Corp. | 10 |
| Firefly | Firefly Global | 9 |
| PeriOptix | DEN-MAT Holdings, LLC | 6 |
| Dr. Vampa | Dr Vampa S.R.L. | 5 |
| Adlite™ II | American Diagnostic Corp. | 5 |
| Emsrun | Wuxi Emsrun Technology Co., Ltd. | 4 |
| MDF® | MDF Instruments Medifriend Inc. | 4 |
| Portaled | Ecleris SRL | 4 |
Showing 12 of 309. All products under Light, Examination, Medical, Battery Powered
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.