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.

Disposable 5mm Laparoscopic Trocar with CE & ISO 13485 Certificate

Name: Disposable 5mm Laparoscopic Trocar with CE & ISO 13485 Certificate
Brand: Guangzhou T.K Medical Instrument Co., Ltd.
SKU: 1958337255

Guangdong, ChinaGuangzhou T.K Medical Instrument Co., Ltd.

US$12.80-17.80

20 Pieces

Sample price:US$13.00/piece.Request sample

Product profile

Customization

Available

Material

Plastic

Ethylene Oxide Sterilization

Model NO.

T05-100-A

Quality Guarantee Period

3 Years

Group

Laparoscopic Surgery

Transport Package

Carton

Specification

5mm with 100mm length

Trademark

Origin

China

HS Code

9018909000

Production Capacity

100000

Key features

FDA 510K Approval: Obtained FDA 510K Letter K193272 for GTK Trocars, ensuring regulatory compliance.

CE & ISO 13485 Certified: Holds valid CE certificate HD 60147623 0001 and ISO 13485:2016 quality management certification.

Universal Instrument Compatibility: No adapter needed between 5mm and 15mm instruments; compatible with all surgical tools.

100% Leak-Proof Design: Universal seal allows replacement without removing cannula, ensuring zero leakage.

Ergonomic Safety Thread: Stable instrument fixation with reduced risk of skin harm during surgery.

Detachable Sealing Components: Allows easy removal of large tissue or organs without complex disassembly.

Flexible Customization Options: Offers minor, full, and design-based customization with ODM and OEM services.

Global Export Experience: Exported to over 40 countries including USA, UK, Germany, and Japan for 21 years.

Company profile

Importers and ExportersHigh Repeat Buyers ChoiceCooperated with Fortune 500Years of Export Experience

Guangzhou T.K Medical Instrument Co., Ltd.

Guangdong, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 21 Years CertifiedNearest Port: Guangzhou Port, Shenzhen PortAverage Response Time: ≤2.64h

AI-Powered supplier vetting

SummaryThe supplier is a medical-device manufacturer with 17 years of stated development and manufacturing experience, 17 years of R&D engineer experience, nine production lines, and 21–30 quality-control staff. It reports CE marking for all GTK Medical products and sales to more than 40 countries, including the United States, Germany, the United Kingdom, France, Italy, Spain, Belgium, Japan, and South Korea. The supplier holds or reports ISO45001:2018, ISO14001, CE, and RoHS-related certifications or capabilities. Its R&D profile includes recent new-product development, more than 600 patent applications, more than 200 granted patents, 3D design, ODM, OEM, SDK, and multiple customization services. Service procedures, corrective-action processes, and complaint-handling records are reported. Limitations include no valid manufacturing-capacity contract with related subcontractors, no overseas warehouse or showroom, and no stated overseas-service country coverage despite reporting overseas agents or branches....

Supplier typeThe supplier is identified as a hi-tech medical-device company focused on development and manufacturing, with 17 years of stated experience. Its product description and medical-device R&D positioning support classification as a medical-device manufacturer rather than a general trading or service company.

CertificationsThe supplier states that all GTK Medical products are CE marked and reports CE and RoHS product-certification capability. It also lists ISO45001:2018 and ISO14001 under sustainable-development management certifications; however, the supplier-management-system certification field is only recorded as “Others,” so the full certification scope is not completely specified.

After-Sales capabilityThe supplier reports written and followed procedures for service assessment, corrective and preventive actions, and customer complaints, along with inventory capability and service through overseas agents or branches. It also reports participation in MEDICA, CES, and WHX DUBAI, but has no overseas warehouse or showroom and states zero countries for overseas services, creating a limitation in documented international service coverage.

R&D capabilityThe supplier reports 17 years of R&D engineer experience, new products during the past year, available SDK capability, ODM and OEM services, and more than 600 patent applications including more than 200 granted patents. These are explicit indicators of established product-development and innovation capability.

Production capacityThe supplier operates nine production lines and has 21–30 quality-control staff, while also reporting in-stock capability and average peak- and off-season lead times of within 15 workdays to one month. Nevertheless, it states that neither the factory nor related subcontractors have a valid manufacturing-capacity contract, which is a documented production-governance weakness.

Customization capabilityThe supplier provides 3D software design services and supports flexible, minor, full, design-based, and sample-based customization. Its reported ODM, OEM, and SDK capabilities further support the ability to adapt or develop products for customer requirements.

Client casesThe supplier states that its products are sold in more than 40 countries, including multiple developed markets, and reports OEM service for well-known brands. Participation in MEDICA, CES, and WHX DUBAI provides additional evidence of market-facing activity, although no specific customer names or individually verifiable case details are supplied.

Product Q&A

Q:Are you a factory or trading company?

Yes. We are a factory in China with 17 years surgical devices developing and manufacturing experience.

Q: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.

Q:What makes GTK Trocars stand out?

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?

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?

Yes. We exported to more than 40 countries, most of which are based in the America and Europe.