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Mdr CE Marked Medical Laparoscopic Instruments Veress Needle Pneumoneedle

Name: Mdr CE Marked Medical Laparoscopic Instruments Veress Needle Pneumoneedle
Brand: Guangzhou T.K Medical Instrument Co., Ltd.
SKU: 2164409015

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

US$3.50-5.50

1,000 Pieces

Product profile

Customization

Available

Type

Surgical Needle & Hook

Application

Abdominal

Model NO.

VN-120

Material

Plastic

Feature

Disposable

Certification

CE, FDA, ISO13485

Needle Size

14 G

Working Length

120mm, 150mm

Transport Package

Sterile Packing

Specification

MDR CE, & ISO13485

Trademark

Origin

China

HS Code

9018321000

Production Capacity

500, 000 PCS/Year

Key features

CE and FDA Certified: Meets international safety standards with CE, FDA, and ISO13485 certifications.

Disposable Design: Eliminates reprocessing risks like blunt needles or jammed mechanisms.

Green Indicator System: Ensures safe penetration of the abdominal cavity during surgery.

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

Multiple Length Options: Available in 120mm and 150mm working lengths to suit different needs.

High Quality Materials: Features sharp 304 stainless steel needles with strong polycarbonate handles.

OEM and ODM Services: Offers flexible, minor, and full customization from designs or samples.

100% Quality Inspection: Every needle undergoes 16 quality inspection steps including function and visual checks.

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.