Kera®starSplint Bio
Kera®starSplint Bio Co-polymer for the production of therapeutic splints 98.0 x 16 mm
16manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Fujian (4), Guangdong (4), Zhejiang (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Dongguan Vigor Textile Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Dongguan Suscong Healthcare Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Cixi Cijia Handicraft Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 7 |
| Changzhou Well Lands Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| Suzhou Kingstone Garments Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Orthotech Rehabilitation Co., Ltd. | Xiamen | Fujian | Manufacturer | 26 |
| Xiamen J-Brace Medical Equipment Co., Ltd. | Xiamen | Fujian | Repacker / relabeller | 24 |
| BUY Asia Enterprise Ltd | Dongguan | Guangdong | Private-label distributor | 22 |
| Hengshui Xukang Medical Appliances Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 21 |
| Liven Sports MFG. (Xiamen) Co., Ltd. | Xiamen | Fujian | Manufacturer | 21 |
| Zhejiang Rehan Medical Manufacturing Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 20 |
Showing 12 of 16. All 16 manufacturers in China registered for Splint, Temporary Training
Record
| Listed by | Eisenbacher Dentalwaren ED Gmbh, Germany |
|---|---|
| FDA product code | IQM |
| Device type | Splint, Temporary Training |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3025 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11051216 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 4 |
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.