FDA Registration
Active
🇨🇳 China
SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
Reg #: 3015697152
·
FEI: 3015697152
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- SHENZHEN ZHENGKANG TECHNOLOGY CO., LTD.
- Registration Number
- 3015697152
- FEI Number
- 3015697152
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2&3/F,Building A, No.3 FuXing Yi Lane, HeHua Community, PingHu Street, LongGang District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K203707
Owner / Operator
- Firm Name
- ShenZhen ZhengKang Technology Co., Ltd.
- Operator Number
- 10062909
- Address
- 2&3/F,Building A, No.3 FuXing Yi Lane, HeHua Community, PingHu Street, LongGang District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518100
- Country
- CN
- Correspondent
- Huayong Yang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-04-01 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2025-02-27 |
| Thermometer Kit | PXH | Class 2 | General Hospital | No | 2020-04-16 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2020-03-13 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-12-26 |
Proprietary Names
Infrared Forehead Thermometer
Sport-Type Pulse Oximeter
Oximeter(Model: JZK-301A, JZK-302, JZK-303A, JZK-304, JZK-305A, JZK-306, JZK-307A, JZK-308, JZK-309A)
Thermometer kit
Upper Arm Blood Pressure Monitor, Models: ZK-B881, ZK-B882, ZK-B883, ZK-B885
Upper Arm Blood Pressure Monitor, Models: ZK-B868, ZK-B869, ZK-B872,ZK-B876
Oximeter
Establishment Types
Manufacture Medical Device