Top1 Manufacturer Bladeless Trocar with Stability Sleeve Mdr CE FDA Certificates

• Customization: Available
• Type: Medical Devices
• Material: Metal, Plastic
• Ethylene Oxide Sterilization: Ethylene Oxide Sterilization
• Quality Guarantee Period: Three Years
• Group: Laparoscopic Surgery Patients
• Logo Printing: With Logo Printing
• Color: Blue
• OEM: Yes
• MOQ: 1
• Transport Package: Peel Pouch Packaging
• Specification: 5mm*55mm
• Trademark: TK
• Origin: China
• HS Code: 9018909000
• Production Capacity: 100000

Product Description

TOP1 Laparoscopic Trocar china Manufacturer, 20years medical devices manufacturing expertise ,trustable and reliable.
sable.
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Detailed Photos

   MDR CE certificate laparoscopic disposable trocars for 3mm,5mm,10mm,12mm,15mm endoscopic surgery.

 

 

 

 

Product Parameters

 

Trocars (CT-A)
Specification
Product Code	Number of Cannula	Diameter (mm)	Working Length (mm)
T05-100-CT-A	1 pc 5mm	5	100
T10-100-CT-A	1 pc 10mm	10	100
T12-100-CT-A	1 pc 12mm	12	100
2T052-CT-A	2 pcs 5mm	5	100
2T102-CT-A	2 pcs 10mm	10	100
2T122-CT-A	2 pcs 12mm	12	100
4T52102-CT-A	2 pcs 5mm & 2 pcs 10mm	5 & 10	100
4T52122-CT-A	2 pcs 5mm & 2 pcs 12mm	5 & 12	100

 

Company Profile

Guangzhou 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.

 

 

Certifications

We 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, 2020

CE 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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