FDA Registration
Active
🇨🇳 China
SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3015007456
·
FEI: 3015007456
·
Expires 2026
Products
7
Proprietary Names
10
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- SHENZHEN IMDK MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3015007456
- FEI Number
- 3015007456
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street,, Guangming District,518107,Shenzhen,PEOPLE'S REPUBLIC OF CHINA.
- City
- SHENZHEN Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K243118
Owner / Operator
- Firm Name
- Shenzhen IMDK Medical Technology Co., Ltd.
- Operator Number
- 10058601
- Address
- 904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street,, Guangming District,518107,Shenzhen,PEOPLE'S REPUBLIC OF CHINA.
- City
- SHENZHEN
- State
- Guangdong
- Postal Code
- 518106
- Country
- CN
- Correspondent
- XIA YUAN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-12-02 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2024-12-02 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2020-11-15 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-10-28 |
| Monitor, Ultrasonic, Fetal | KNG | Class 2 | Obstetrics/Gynecology | No | 2018-10-13 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2024-04-23 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2024-04-23 |
Proprietary Names
Arm Blood Pressure Monitor (model: BPM-A7L)
Arm Blood Pressure Monitor (model: BPM-A7VL)
Arm Blood Pressure Monitor (model: BPM-A7)
Arm Blood Pressure Monitor (model: BPM-A7V)
Pulse Oximeter-C101A2 C101H1 C101B1 C101B2 C101A3
Pulse Oximeter (Model C101a2, C101b1, C101a3)
Pulse Oximeter C101H1
Ultrasonic Doppler (Model YM-2T8)
Wrist Blood Pressure Monitor
EMS/TENS Massager Device
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device