US$5.00-15.00
|
5 Pieces
(MOQ)
|
Basic Info.
Application
Clinical, Household
Certification
CE, FDA, ISO13485
Product Description
TOP1 Laparoscopic Trocar china Manufacturer, 20years medical devices manufacturing expertise ,trustable and reliable. visable.
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Detailed Photos
MDR CE FDA certificate laparoscopic disposable trocars for 3mm,5mm,10mm,12mm,15mm endoscopic surgery.
Product Parameters
Company ProfileGuangzhou T.K Medical, a high-tech enterprise specializing in medical devices for 18 years, has been dedicated to the research, development, and production of minimally invasive surgical instruments and novel oral care products. Operating from a modern factory spanning over 10,000+ square meters, we have assembled a team of 140+ medical industry professionals who drive our innovation and growth. Over the years, we have successfully applied for more than 700+ domestic and international patents,highlighting our strong R&D capabilities and laying a solid foundation for our long-term development. Today, our products are sold in over 40+ countries worldwide, generating an annual output value exceeding 100,000,000+ and earning widespread international recognition. In the future, Guangzhou T.K Medical will continue to embrace innovation, providing more advanced and efficient medical solutions to patients globally, and writing a new chapter in the cause of human health.
CertificationsWe adhere to strict quality control processes and systems and have been granted 700+ domestic and international patents, including 400+ authorized patents,with our products leading in the industry.
FDA 510K Approval
FDA 510K Letter: K193272
Trade/Device Name: GTK Trocars
Regulation Number: 21 CFR 876.1500
Date: July 6, 2020CE certificate
Registration No.: HD 60147623 0001
Report No.: 17025753 014
Effective Date: July 24, 2020 Packaging & Shipping
FAQ
Trocars |
Q: Are you a factory or trading company? |
A: Yes. We are a factory in China with 20 years surgical devices developing and manufacturing experience. |
Q: What is the core strength of GTK Medical? |
A: Our core strength is strong R&D Capability (more than 600 patents applied) and world first class quality (FDA 510K, CE, ISO13485:2016) management on products. |
Q: What makes GTK Trocars stand out? |
A: Excellent sealing performance plus excellent smooth insertion and removal of surgical instruments. |
Q: Do you provide free samples of GTK Trocars for clinical trial use? |
A: Yes. We are proud and confident to provide free samples for real clinical testing and evaluation. |
Q: Do you have exported experiences to large medical devices company/companies? |
A: Yes. We exported to more than 40 countries, most of which are based in the America and Europe. |
Q: Do you accept factory audit prior to formal partnership? |
A: Yes. We are proud and confident to accept factory audit. We passed US FDA on site aduits on 2015 and 2021. |
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