FDA Registration
Active
🇨🇳 China
CHINA QINGDAO BRIGHT MEDICAL MANUFACTURING CO.,LTD.
Reg #: 3007048259
·
FEI: 3007048259
·
Expires 2026
Products
8
Proprietary Names
5
Establishment Types
3
Classifications
8
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Registration Details
- Registration Name
- CHINA QINGDAO BRIGHT MEDICAL MANUFACTURING CO.,LTD.
- Registration Number
- 3007048259
- FEI Number
- 3007048259
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.1 Tiankang Road, Chengyang District
- City
- Qingdao Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K200540
Owner / Operator
- Firm Name
- China Qingdao Bright Medical Manufacturing CO.,Ltd.
- Operator Number
- 10025835
- Address
- No.1, Tiankang Road, Chengyang District
- City
- Qingdao
- State
- Shandong
- Postal Code
- 266107
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2020-06-03 |
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2016-09-20 |
| Uterine Electromyographic Monitor | OSP | Class 2 | Obstetrics/Gynecology | No | 2016-09-20 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2014-09-23 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2008-05-13 |
| Device, Vein Location, Liquid Crystal | KZA | Class 1 | General Hospital | No | 2013-01-22 |
| Electrode, Electrocardiograph, Multi-Function | MLN | Class 2 | Cardiovascular | No | 2018-04-19 |
| Tester, Electrode/Lead, Electroencephalograph | GYA | Class 1 | Neurology | No | 2015-09-06 |
Proprietary Names
BRAINSTREAM Disposable Deep Cup EEG Electrodes
OB-Tools Ltd.
Electrode.Electrocardiograph 40494E - Limb Clamp Electrode
Qingdao Brgiht
Gel Electrode
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device