FLX-Lite
FLX-Lite, Sterile, Single USE, Flexible Surgical Lite, 254 MM (10")
53manufacturers in China registered for this device type
2catalogue 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 | ConMed Corporation, United States |
|---|---|
| FDA product code | KYT |
| Device type | Light, Examination, Medical, Battery Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
| Record revised | 2024-08-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: KEEP DRY |
| Packaging | Box of 10, box of 3 |
| Sizes | Length 5 to 10 in; length 127 to 254 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3058A | Length 5 in | 10 | In distribution |
| 3034A | Length 10 in | 3 | 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 |
| SurgiTel | Surgitel | 7 |
| 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 |
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.