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Sign in to claim this brandShenzhen Changke Connect Electronics Co., Ltd.
US
Last updated May 27, 2026
What Shenzhen Changke Connect Electronics Co., Ltd. makes
The company manufactures single-use and reusable electrocardiographic lead sets for cardiac monitoring, reusable blood pressure cuffs for blood pressure measurement, and neurophysiologic monitoring systems for real-time patient data acquisition. These products are designed for clinical use in hospitals, diagnostic centers, and patient care settings to support cardiac and hemodynamic assessments.
All listed devices fall under FDA Class II regulation and are included in the FDA’s Unique Device Identifier (UDI) database. The company’s products are authorised for commercial distribution in the United States under this regulatory framework.
Written from this company's registered devices by an AI model, 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
- 529906512
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Changke Connect | CK-SMD-582A1-03AR2 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00574 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00565 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00575 | FDA UDI | Class II | Active |
| Changke Connect | CK-SMD-A82A1-03AN2 | FDA UDI | Class II | Active |
| Changke Connect | CK-SMD-582A1-05AR2 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00576 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00570 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00577 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00573 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00572 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00578 | FDA UDI | Class II | Active |
| Changke Connect | CK-SMD-481A1-12AR2 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00566 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00569 | FDA UDI | Class II | Active |
| Changke Connect | GCF1204 | FDA UDI | Class II | Active |
| Changke Connect | CK-SMD-982A1-05AR2 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00563 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00568 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00562 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00564 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00571 | FDA UDI | Class II | Active |
| Changke Connect | P01-001-00567 | FDA UDI | Class II | Active |
| Changke Connect | GCF1205 | FDA UDI | Class II | Active |
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