What are the payment terms?

We accept Small-amount payment, D/P, T/T, LC, Western Union, and PayPal.

What is the lead time for production?

Lead time is within 15 workdays during off-season and within one month during peak season.

Are you a factory or trading company?

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

FDA 510K Approved CE Certificate Veress Needle Insullation Needle

Name: FDA 510K Approved CE Certificate Veress Needle Insullation Needle
Brand: Guangzhou T.K Medical Instrument Co., Ltd.
SKU: 1970238125

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

US$3.50-5.50

1,000 Pieces

Sample price:US$10.00/piece.Request sample

Product profile

Customization

Available

Type

Surgical Needle & Hook

Application

Abdominal, Microsurgery, Anorectal, Urology

Model NO.

VN-120

Material

Steel

Feature

Disposable

Certification

CE, FDA, ISO13485

Group

Adult

Working Length

120mm

Ventilation Capacity

Custmization

Yes

Transport Package

Peel Pouch Package

Specification

ISO13485, CE

Trademark

Origin

China

HS Code

9018321

Production Capacity

500, 000 PCS/Year

Key features

FDA 510K & CE Certified: Products hold FDA 510K, CE, and ISO13485 certifications for global compliance.

17 Years Manufacturing Expertise: Over 17 years of R&D and manufacturing experience in surgical devices.

Double Warning System: Ensures safe insertion with a double warning system for enhanced precision.

Ergonomic Handle Design: Designed for convenient and easy insertion during laparoscopic procedures.

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

Strong R&D Capability: Holds more than 600 applied patents, including over 200 granted patents.

Free Samples Available: Provides free samples for clinical testing and evaluation upon request.

Factory Audit Accepted: Passed US FDA on-site audits in 2015 and 2021; welcomes factory audits.

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: ≤2.95h

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.