FDA Registration
Active
🇨🇳 China
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
Reg #: 3008261717
·
FEI: 3008261717
·
Expires 2026
Products
9
Proprietary Names
17
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
- Registration Number
- 3008261717
- FEI Number
- 3008261717
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 301, No. 16 Xianghong Road
- City
- Xiamen Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K182117
Owner / Operator
- Firm Name
- Xiamen Compower Medical Tech. Co., Ltd.
- Operator Number
- 10031696
- Address
- Unit 301, No.16, Xianghong Road,, Xiang' An Torch Industrial Zone,
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361101
- Country
- CN
- Correspondent
- Lifen Chen
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2022-06-30 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2012-04-10 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2023-11-23 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2010-03-01 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2017-12-06 |
| Cardiopulmonary Resuscitation Aid Kit | OEV | Class 2 | Anesthesiology | No | 2017-12-17 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-11-24 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2021-08-27 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2017-12-17 |
Proprietary Names
Collar,Adjustable Collars, Fixed Collars
Oropharyngeal Airway
Vinyl patient exam gloves powder free
Anesthesia mask
CPR Mask with Oxygen Port
Non-Rebreathing Valve (18.5mm)
CPR Mask without Oxygen Port
Non-Rebreathing Valve (15mmOD)
Infant CPR Mask with Oxygen Port
Cardiopulmonary Resuscitation Aid Kit, with CPR Mask
Polymer patient examination glove
Manual emergency ventilator Resuscitator
PVC Manual Resuscitator
Disposable Manual Resuscitator
Nitrile exam glove
PF nitrile exam glove,blue color
Pad, alcohol, device disinfectant
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device