Xiamen Compower Medical Tech. Co., Ltd.
Manufacturer and brand owner in Xiamen, Fujian, China. 9 device types, 44 products catalogued, 2 clearances.
Xiamen Compower Medical Tech. Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Orthosis, Cervical, Mask, Gas, Anesthetic and 7 other device types. 28 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
Registration
| Registered name | XIAMEN COMPOWER MEDICAL TECH. CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008261717 |
| FEI number | 3008261717 |
| DUNS | 543482946 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 厦门康勃医疗科技有限公司 |
|---|---|
| Unified social credit code | 91350200784173101N |
| Source | NMPA UDI database |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | Unit 301 |
| Postal code | 361115 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Oropharyngeal Airway | 2012 | 84 |
| Cardiopulmonary Resuscitation Aid Kit | Class 2 | Cardiopulmonary Resuscitation Aid Kit, with CPR Mask | 2017 | 3 |
| Mask, Gas, Anesthetic | Class 1 | Anesthesia mask | 2010 | 71 |
| Orthosis, Cervical | Class 1 | Collar,Adjustable Collars, Fixed Collars | 2022 | 114 |
| Pad, Alcohol, Device Disinfectant | Class U | Pad, alcohol, device disinfectant | 2017 | 49 |
| Polymer Patient Examination Glove | Class 1 | Polymer patient examination glove, Nitrile exam glove, PF nitrile exam glove,blue color | 2023 | 83 |
| Valve, Non-Rebreathing | Class 2 | CPR Mask with Oxygen Port, Non-Rebreathing Valve (15mmOD), CPR Mask without Oxygen Port, Non-Rebreathing Valve (18.5mm), Infant CPR Mask with Oxygen Port | 2017 | 19 |
| Ventilator, Emergency, Manual (Resuscitator) | Class 2 | PVC Manual Resuscitator, Disposable Manual Resuscitator, Manual emergency ventilator Resuscitator | 2021 | 8 |
| Vinyl Patient Examination Glove | Class 1 | Vinyl patient exam gloves powder free | 2023 | 72 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Compower | CAE | 29 |
| Compower | BSJ | 29 |
| Compower | CBP | 16 |
| Medline | CAE | 9 |
| Ever One | CAE | 8 |
| Typenex | BSJ | 7 |
| Ever Ready First AID | CAE | 7 |
| WNL product | CBP | 6 |
| Compower | BTM | 6 |
| MCR | BSJ | 4 |
| Compower | BTK | 2 |
| EMI | BTM | 2 |
| Ever Ready First AID | BSJ | 2 |
| Lightning X | BTM | 2 |
| Mendyoumedical | CBP | 1 |
| EMI | OEV | 1 |
| Ever Ready | CAE | 1 |
| Spiracle Technology | CBP | 1 |
| Naui | CBP | 1 |
| Lightning X Products, Inc | CBP | 1 |
| Lightning X Products, Inc | CAE | 1 |
| MY Medic | CBP | 1 |
| EMI | CBP | 1 |
| Lightning X Products, Inc | IQK | 1 |
| American Red Cross | CBP | 1 |
| Lightning X Products, Inc | BTM | 1 |
| GFA | CBP | 1 |
| Kemp USA | CAE | 1 |
Clearances
2 clearances name Xiamen Compower Medical Tech. Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K210288 | 2021-08-26 | BTM | Traditional | This company |
| K171961 | 2017-11-17 | CBP | Traditional | This company |
| K210723 | 2021-07-12 | LZA | Traditional | Jiangxi Zhonghong Pulin Medical Products Co., Ltd. |
| K182117 | 2018-10-06 | LYZ | Traditional | Jiangxi Zhonghong Pulin Medical Products Co., Ltd. |
| K152712 | 2016-03-09 | LZA | Traditional | Zhonghong Pulin Medical Products Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Main products | Manual resuscitators, Resuscitator accessories |
| Certifications | Medical Device Manufacturing Enterprise License |
Nearby Manufacturers
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.