🌍 CHANGMEI Kyphoplasty Since 2013 ⭐ 13+ Year Industry Experience ✓ Verified Elite Supplier
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CHANGMEI Kyphoplasty
www.czmed.com
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FDA Establishment Registration & Device Listing, 510 (k) Premarket Notification, Quality Management System Certificate, EU Quality Assurance Certificate (MDR), EU Quality Management System Certificate (MDR)
Plant Area 51,985 m²
Number of Employees 235
CHANGMEI Kyphoplasty
Factory area:
51,985 m²
Company size :
235
Jiangsu Changmei Medtech Co., Ltd., established in 2013 and headquartered in Jiangsu, China, is a vertically integrated medical device manufacturer specializing in the full-cycle development of minimally invasive surgical instruments—from original design and prototyping through regulatory clearance to commercial-scale production. The company's core product portfolio includes CE-certified and FDA-cleared kyphoplasty systems, dilation balloon catheters, and endoscopic instruments, with in-house capabilities spanning CNC machining, laser welding, balloon forming, and ISO Class 7 cleanroom assembly under an ISO 13485-certified quality system.
Changmei's kyphoplasty balloon catheters have secured approximately 80% of the Chinese domestic market, establishing the company as the country's leading supplier in this category. The company also serves as a trusted OEM and supply partner to member companies of global medtech leaders Stryker and Medtronic, with products distributed across Europe, North America, and the Asia-Pacific region.
A flagship innovation is the company's 1.0mm mini biopsy forceps—the first ultra-thin biopsy forceps independently developed in China and cleared under both CE and FDA pathways. Featuring a 1.0mm jaw diameter compatible with 1.20mm instrument channels, the device incorporates a four-bar linkage structure and alligator-tooth cup design that deliver enhanced pushability and reliable tissue sampling even in narrow peripheral bronchi. This specification enables successful transbronchial biopsy in airway segments where conventional forceps cannot reach.
Backed by a cross-disciplinary team with deep expertise in medical device engineering and manufacturing processes, Changmei Medtech continues to expand its pipeline of minimally invasive solutions. The company remains committed to advancing balloon catheter and endoscopic technologies that improve clinical outcomes for patients worldwide.
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