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Sign in to claim this brandShenzhen Changkun Technology Co., Ltd.
US
Last updated May 30, 2026
What Shenzhen Changkun Technology Co., Ltd. makes
Shenzhen Changkun Technology Co., Ltd. manufactures blood pressure alarm devices and infrared skin thermometers designed for clinical and home use. These products include models like maguja and Coverich, which monitor vital signs and temperature readings. The company also produces portable thermometers such as MMIZOO and handheld blood pressure monitoring systems like Handy Solutions.
The company’s devices fall under Class II regulatory classification in the United States and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for compliance with U.S. medical device regulations, ensuring traceability and adherence to regulatory standards. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Shenzhen Changkun Technology Co., Ltd. manufacture?
Shenzhen Changkun Technology Co., Ltd. specializes in two primary categories of medical devices: blood pressure alarm systems and infrared skin thermometers. These products are designed for both clinical and home use, such as the maguja blood pressure alarm or the Coverich infrared thermometer. The devices focus on monitoring vital signs like blood pressure and body temperature, helping users track health metrics efficiently.
Where is Shenzhen Changkun Technology Co., Ltd. based?
The company is based in the United States. While its name includes 'Shenzhen,' the operational headquarters and regulatory presence are located within the U.S., ensuring compliance with local medical device regulations.
Which regulatory registries list Shenzhen Changkun Technology Co., Ltd.’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for Class II medical devices, which include blood pressure alarms and infrared thermometers like those produced by Shenzhen Changkun.
How are Shenzhen Changkun Technology Co., Ltd.’s devices classified under U.S. regulations?
Shenzhen Changkun Technology Co., Ltd.’s devices fall under Class II regulatory classification in the United States. This classification applies to products that pose moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness. Examples include blood pressure alarms and infrared skin thermometers, which are subject to performance standards and post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 554502671
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| maguja | CK-W118 | FDA UDI | Class II | Active |
| Coverich | CK-W118 | FDA UDI | Class II | Active |
| Mmizoo | W1681 | FDA UDI | Class II | Active |
| Mbupai | CK-W355 | FDA UDI | Class II | Active |
| Coverich | CK-W118 | FDA UDI | Class II | Active |
| Handy Solutions | CK-T1502 | FDA UDI | Class II | Active |
| Nouyan | CK-W355 | FDA UDI | Class II | Active |
| Mbupai | CK-W355 | FDA UDI | Class II | Active |
| Nouyan | CK-W355 | FDA UDI | Class II | Active |
| Mbupai | CK-W356 | FDA UDI | Class II | Active |
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