Best Selling Laparoscopic Instruments Disposable Trocar Cannula Disposable Surgical Trocars
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Product Highlights
- 20 Years Manufacturing Expertise: Over two decades of experience in surgical device development and manufacturing.
- FDA 510K & CE Certified: Products hold FDA 510K approval and CE certification for global market access.
- 700+ Patents Applied: Strong R&D capability with over 700 domestic and international patents.
- Flexible Customization Options: Offers flexible, minor, and full customization including designs and samples.
- Global Export Experience: Exported to over 40 countries, primarily in North America and Europe.
- Ethylene Oxide Sterilization: All trocars are sterilized using Ethylene Oxide for immediate clinical use.
- Free Clinical Trial Samples: Free samples provided for real clinical testing and evaluation upon request.
- Factory Audit Accepted: Factory audits are welcome; passed US FDA on-site audits in 2015 and 2021.
Product Attributes
- Customization
- Available
- Type
- Medical Devices
- Material
- Metal, Plastic
- Model NO.
- T10-100-CT-A
- Ethylene Oxide Sterilization
- Ethylene Oxide Sterilization
- Quality Guarantee Period
- Three Years
- Group
- Laparoscopic Surgery Patients
- Logo Printing
- With Logo Printing
- Color
- Transparent Blue
- Sizes
- 5mm, 10mm, 12mm
- Transport Package
- Blister Box Packaging
- Specification
- all sizes available
- Trademark
- TK
- Origin
- China
- HS Code
- 9018909000
- Production Capacity
- 100000
Product Images of Best Selling Laparoscopic Instruments Disposable Trocar Cannula Disposable Surgical Trocars
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Best Selling Laparoscopic Instruments Disposable Trocar Cannula Disposable Surgical Trocars -
Best Selling Laparoscopic Instruments Disposable Trocar Cannula Disposable Surgical Trocars -
Best Selling Laparoscopic Instruments Disposable Trocar Cannula Disposable Surgical Trocars -
Best Selling Laparoscopic Instruments Disposable Trocar Cannula Disposable Surgical Trocars -
Best Selling Laparoscopic Instruments Disposable Trocar Cannula Disposable Surgical Trocars -
Best Selling Laparoscopic Instruments Disposable Trocar Cannula Disposable Surgical Trocars -
Best Selling Laparoscopic Instruments Disposable Trocar Cannula Disposable Surgical Trocars
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Product Description
TOP1 Laparoscopic Trocar china Manufacturer, 20years medical devices manufacturing expertise ,trustable and reliable.
G T.K trocars have been exported to 40 countries, most of which are European and American countries, such as the USA, UK, France, Germany, Italy, Belgium, Spain, Japan, South Korea.
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MDR CE FDA certificate laparoscopic disposable trocars for 3mm,5mm,10mm,12mm,15mm endoscopic surgery.
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
Report No.: 17025753 014
Effective Date: July 24, 2020
| 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. |
Please do not hesitate to contact me, I am always here waiting for assisting you!
About the Supplier
This supplier has been audited by BV. Verify the report on the official BV website with ID "MIC-ASR261094". Items marked "
" are certified.
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Company Profile
G T. K Medical is based in China as a TOP1 manufacturer of laparoscopic instruments for 20 years.
Here are a few our core strengths compared to other manufacturers.
I am confident that we will be your long term win-win partner. Here are a few our core strengths compared to other Chinese manufacturers.
1. FDA 510K registration issued by FDA on GTK Trocars and GTK Veress Needles. We are the ONLY Manufacturer in China who obtained the FDA 510K registrations for trocars and veress needles.
2. We export trocars, retrieval bags and veress needles to 50 countries like USA, UK, France, Germany, Italy, Belgium, Spain, Japan, South Korea.
3. We have MDR, CE Certificate, ISO13485: 2016 Certificate for medical devices.
Our History
Found in 2004, Guangzhou T. K Medical Instrument Co., Ltd. is a hi-tech company which focuses on the development & Manufacturing of medical devices for 17 years.
T. K Medical has strong innovative capability on R& D of medical devices. T. K Medical has applied more than 600 patents at home and abroad, including more than 200 granted patents.
Our Philosophy
The ultimate goal of T. K Medical is: New science and technology, new life;
To create future with innovation; To benefit human health with technology.
Our Quality System
The Quality Policy of T. K Medical is "Human-oriented, quality first, continuous improvement, perfection seeking".
T. K Medical passed GMP of NMPA (China FDA) and US FDA Factory registration (Factory registration number is 3008191256) and is ISO 13485: 2016 Certified.
Our Product Quality
All GTK Medical products are CE marked; GTK products are sold to more than 40 countries, including developed countries such as America, Germany, U. K, France, Italy, Spain, Belgium, Japan, South Korea etc.
About Our Factory & Business Background
-
Business Type
- Manufacturer/Factory & Trading Company
- Address
- No. 7, Jianye Six Road, East Zone of Guangzhou Economic and Technological Development District, Guangzhou, Guangdong, China
-
Plant Area
- 8130 square meters
-
Number of Employees
- 155
-
Registered Capital
- 18,000,000 RMB
-
Terms of Payment
- Small-amount payment, D/P, T/T, LC, Western Union, PayPal
-
International Commercial Terms(Incoterms)
- FOB, CIF, CFR, EXW
-
Average Lead Time
-
Peak Season Lead Time: within 15 workdays, one month
Off Season Lead Time: within 15 workdays, one month -
Nearest Port
- Guangzhou Port, Shenzhen Port
-
Minimum Order Quantity
- 1 PCS
-
Supply Chain Partners
- 100
Our Production Capability & Technical Expertise
-
Main Products
- Laparoscopic Products, Trocars, Retrieval Bags, Veress Needles, Wound Retractors, Wound Protectors, Vacuum Bells, 4K Endoscope Camera System, Laparoscopic Surgical Instruments
-
Production Lines
- 1
-
Production Machines
- Air Leakage Detector, Air Purifi cation System, Drying Machine, Purifi ed Water Purifi cation System, Gas Chromatograph, Tip Bending Tester, Water Purifi cation Filtration Equipment
-
QA/QC inspectors
- 14 people
-
Inspection Type for Finished Products
- 100% inspection(Function inspection & Visual inspection)
-
Inspection Method for Finished Products
- Have instructions and uniformly followed
-
Customization Options
- Flexible customization, Minor Customization, Full Customization, Customization from Designs, Customization from Samples
-
ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 23 people
-
Traceability of Raw Materials
- Yes
-
Own Brand
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2004-03-03
-
Export Year
- 21 Years
-
Main Markets
- North America, South America, Europe, Southeast Asia/ Mideast, East Asia(Japan/ South Korea), Australia
-
Number of Foreign Trading Staff
- 5
-
Overseas Agent/Branch
- Yes
-
New Products Launched in Last year
- Yes
Our Certifications, Standards & Industry Recognition
-
Product Certification
- CE, RoHS, Others
FAQ
- Are you a factory or trading company?
- Yes. We are a factory in China with 20 years surgical devices developing and manufacturing experience.
- What is the core strength of GTK Medical?
- 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.
- What makes GTK Trocars stand out?
- Excellent sealing performance plus excellent smooth insertion and removal of surgical instruments.
- Do you provide free samples of GTK Trocars for clinical trial use?
- Yes. We are proud and confident to provide free samples for real clinical testing and evaluation.
- Do you have exported experiences to large medical devices company/companies?
- Yes. We exported to more than 40 countries, most of which are based in the America and Europe.
- Do you accept factory audit prior to formal partnership?
- 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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