Tracoe® Care
TRACOE cleaning brushes for flexible tracheostomy tubes set
26manufacturers in China registered for this device type
9catalogue 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 | Tracoe Medical Gmbh, Germany |
|---|---|
| FDA product code | EPE |
| Device type | Brush, Cleaning, Tracheal Tube |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5795 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-03-15 |
| Record revised | 2025-05-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: no special storage conditions |
| Distribution end date | 2025-03-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REF 938-B | bristle diameter: 9 mm total length: 21 mm | Withdrawn |
| REF 940-B | bristle diameter: 9 mm total length: 33.5 mm | Withdrawn |
| REF 938-A | bristle diameter: 7 mm total length: 21 mm | Withdrawn |
| REF 940-D | bristle diameter: 13 mm total length: 36.0 mm | Withdrawn |
| REF 940-A | bristle diameter: 7 mm total length: 31.5 mm | Withdrawn |
| REF 938-C | bristle diameter: 11 mm total length: 21 mm | Withdrawn |
| REF 940-C | bristle diameter: 11 mm total length: 36.0 mm | Withdrawn |
| REF 941 | mix of different sizes | Withdrawn |
| REF 939 | mix of different sizes | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 37 |
| 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 |
| Bioseal Inc. | Bioseal | 2 |
| 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.