Bioseal Inc.
Tooth Brush Cleaning Style
26manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (9), Guangdong (6), Zhejiang (5). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Medico Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shanghai Like Brush Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
Showing 12 of 26. All 26 manufacturers in China registered for Brush, Cleaning, Tracheal Tube
Record
| Listed by | Bioseal, United States |
|---|---|
| FDA product code | EPE |
| Device type | Brush, Cleaning, Tracheal Tube |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5795 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 25, case of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17404/25 | In distribution | |
| 17409/50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 37 |
| Tracoe® care | Tracoe Medical Gmbh | 9 |
| InHealth Technologies; Blom-Singer; Advantage | Freudenberg Medical, LLC | 9 |
| Trach Tube Cleaning Brushes | Boston Medical Products, Inc. | 8 |
| InHealth Technologies; Blom-Singer; Dual Valve | Freudenberg Medical, LLC | 6 |
| Grafco | GF Health Products, Inc | 4 |
| Pilling | Teleflex Medical LLC | 4 |
| InHealth Technologies; Blom-Singer | Freudenberg Medical, LLC | 3 |
| XinjingProWellness™ | Tianjin Newtrans Technology Development | 3 |
| Sklar | Sklar Corporation | 3 |
| AincA® | Anesthesia Associates, Inc. | 3 |
| Kmedic | Teleflex Medical LLC | 2 |
Showing 12 of 29. All products under Brush, Cleaning, Tracheal Tube
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.