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Shenzhen Changke Connect Electronics Co., Ltd.

US

Last updated May 27, 2026

Part of Shenzhen Changke Connect Electronics Co., Ltd.

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
—
Website
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LinkedIn
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Facebook
—
Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
529906512

Catalogue (24)

DeviceModel / ReferenceRegistriesClassStatus
Changke Connect CK-SMD-582A1-03AR2
FDA UDI
Class IIActive
Changke Connect P01-001-00574
FDA UDI
Class IIActive
Changke Connect P01-001-00565
FDA UDI
Class IIActive
Changke Connect P01-001-00575
FDA UDI
Class IIActive
Changke Connect CK-SMD-A82A1-03AN2
FDA UDI
Class IIActive
Changke Connect CK-SMD-582A1-05AR2
FDA UDI
Class IIActive
Changke Connect P01-001-00576
FDA UDI
Class IIActive
Changke Connect P01-001-00570
FDA UDI
Class IIActive
Changke Connect P01-001-00577
FDA UDI
Class IIActive
Changke Connect P01-001-00573
FDA UDI
Class IIActive
Changke Connect P01-001-00572
FDA UDI
Class IIActive
Changke Connect P01-001-00578
FDA UDI
Class IIActive
Changke Connect CK-SMD-481A1-12AR2
FDA UDI
Class IIActive
Changke Connect P01-001-00566
FDA UDI
Class IIActive
Changke Connect P01-001-00569
FDA UDI
Class IIActive
Changke Connect GCF1204
FDA UDI
Class IIActive
Changke Connect CK-SMD-982A1-05AR2
FDA UDI
Class IIActive
Changke Connect P01-001-00563
FDA UDI
Class IIActive
Changke Connect P01-001-00568
FDA UDI
Class IIActive
Changke Connect P01-001-00562
FDA UDI
Class IIActive
Changke Connect P01-001-00564
FDA UDI
Class IIActive
Changke Connect P01-001-00571
FDA UDI
Class IIActive
Changke Connect P01-001-00567
FDA UDI
Class IIActive
Changke Connect GCF1205
FDA UDI
Class IIActive

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