Chilecom Medical Devices Co Ltd
Registered establishment in Xiangtan, Hunan, China. 5 device types, 1 clearance.
Chilecom Medical Devices Co Ltd is a manufacturer holding a current FDA establishment registration. The registration covers Stylet, Tracheal Tube, Tube, Tracheal (W/Wo Connector) and 3 other device types. Its earliest product listing with the FDA dates from 2009.
5device types registered with the FDA
1510(k) clearance
Registration
| Registered name | CHILECOM MEDICAL DEVICES CO LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007728072 |
| FEI number | 3007728072 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 博罗其乐康医疗用品有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Xiangtan |
|---|---|
| Province | Hunan |
| Address | 38 Shuyuan Road |
| Postal code | 411101 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | chilecom | 2011 | 58 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | SuperJetNeb, SuperNeb, Chilecom | 2010 | 57 |
| Pump, Nebulizer, Electrically Powered | Class 1 | Super Jet Nebs, SuperNebs, Chilecom | 2010 | 15 |
| Stylet, Tracheal Tube | Class 1 | Chilecom, Tracheal tube stylet | 2011 | 34 |
| Tube, Tracheal (W/Wo Connector) | Class 2 | Chilecom Endotracheal Tubes | 2009 | 9 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K080105 | 2009-02-13 | BTR | Traditional | This company |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Hunan Endoso Life Technology Co., Ltd. | 7 |
| Hunan Vathin Medical Instrument Co., Ltd. | 6 |
| Alps Xiangtan Prosthetic & Orthotic Co., Ltd. | 1 |
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.
The manufacturer named here can complete this record.