Karl Schumacher
Plastic Instrument #5812.5mm Wide X 7.5mm Long Paddle
23manufacturers in China registered for this device type
38catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (5), Guangdong (5), Anhui (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
Showing 12 of 23. All 23 manufacturers in China registered for Instrument, Filling, Plastic, Dental
Record
| Listed by | Karl Schumacher Dental, LLC, United States |
|---|---|
| FDA product code | EIY |
| Device type | Instrument, Filling, Plastic, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2024-02-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KIT0303 | In distribution | |
| PFI2025TI | In distribution | |
| PFI6014T | In distribution | |
| PLA0536 | In distribution | |
| PFI6537T | In distribution | |
| CPS0003 | In distribution | |
| PLA0581 | In distribution | |
| BSH6002 | In distribution | |
| PFI6039T | In distribution | |
| CPS0004 | In distribution | |
| COP6122 | In distribution | |
| PFI6020T | In distribution | |
| PFI6040T | In distribution | |
| PFI6434T | In distribution | |
| PFI6012T | In distribution | |
| PFI6001GT | In distribution | |
| PFI6007T | In distribution | |
| PFI6117T | In distribution | |
| PFI6001T | In distribution | |
| PFI2010TI | In distribution | |
| PFI6028T | In distribution | |
| PFI6050T | In distribution | |
| PFI6514T | In distribution | |
| PFI6534T | In distribution | |
| PFI6023T | In distribution | |
| PFI6022T | In distribution | |
| PFI6002T | In distribution | |
| PFI6024T | In distribution | |
| PFI6000LRT | In distribution | |
| PFI6003T | In distribution | |
| CPS0002 | In distribution | |
| PFI6601AT | In distribution | |
| BSH6005 | In distribution | |
| PFI6460AT | In distribution | |
| PFI6004T | In distribution | |
| PFI6000IOT | In distribution | |
| PFI2012TI | In distribution | |
| COP6113 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy | HU-Friedy MFG Co., LLC | 355 |
| Power Dental USA | Power Dental U.S.A. Inc. | 111 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 107 |
| Reicodent | Devemed Gmbh | 91 |
| American Eagle Instruments | American Eagle Instruments | 79 |
| Stoma® | Storz AM Mark Gmbh | 77 |
| Zoll-Dental | Zoll-Dental | 69 |
| Aesculap | Aesculap AG | 60 |
| devemed | Devemed Gmbh | 58 |
| Osung MND | Osung MND Co., Ltd. | 57 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 41 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 34 |
Showing 12 of 109. All products under Instrument, Filling, Plastic, 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.