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Laparoscopic Insufflation Needle Medtronic with Mdr CE FDA
US$3.50-10.50
1 Piece
Sample price:US$10.00/piece.Request sample
Product profile
Customization
AvailableType
Surgical Needle & HookApplication
Orthopedic, Abdominal, Ent, Neurosurgery, Microsurgery, Anorectal, Urology, BurnsMaterial
SteelFeature
DisposableCertification
CE, FDA, ISO13485, MdrGroup
AdultWorking Length
120mmVentilation Capacity
3LCustmization
YesTransport Package
Peel Pouch PackageSpecification
ISO13485, CETrademark
TKOrigin
ChinaHS Code
9018321Production Capacity
500, 000 PCS/YearKey features
Multi-Certification Compliance: Holds CE, FDA, ISO13485, and Mdr certifications for global market access.
Flexible Customization: Offers full, minor, and design-based customization options for surgical needs.
Disposable Sterile Design: Made of steel with a disposable feature ensuring safety and hygiene in surgery.
Manufacturer Direct Supply: Direct from Guangzhou T.K Medical, a high-tech enterprise with 18 years experience.
Low Minimum Order Quantity: Supports small orders with a Minimum Order Quantity of just 1 PCS.
Global Export Experience: Exported to over 40 countries including USA, UK, Germany, and Japan.
Strong R&D Capability: Backed by 23 R&D engineers and over 700 domestic and international patents.
100% Quality Inspection: Every finished product undergoes strict functional and visual inspection.
Company profile
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: ≤3.40h
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:What certifications does the Veress Needle have?
A:
The needle is certified with CE, FDA, ISO13485, and Mdr standards.
Q:Is the Veress Needle reusable or disposable?
A:
It is a disposable surgical needle made of steel for single-use safety.
Q:Can I customize the specifications of the needle?
A:
Yes, we offer flexible customization including full, minor, and design-based options.
Q:What is the minimum order quantity (MOQ)?
A:
The minimum order quantity is 1 PCS, allowing for small trial orders.
Q:What is the lead time for production?
A:
Lead time is within 15 workdays or one month, depending on the season.
Send Inquiry
*To:
Guangzhou T.K Medical Instrument Co., Ltd.
Guangzhou T.K Medical Instrument Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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