Is the 4K camera waterproof?

Yes, the 4K camera head has an IPX8 waterproof rating, allowing for safe sterilization and reuse.

What certifications does the product have?

The product holds CE, RoHS, FDA 510K, and ISO13485:2016 certifications.

Can I customize the product?

Yes, we offer flexible customization options including OEM/ODM services, minor customization, and full customization from designs or samples.

Endoscopy Camera 4K Equipment CE Certificate Without Trolley

Name: Endoscopy Camera 4K Equipment CE Certificate Without Trolley
Brand: Guangzhou T.K Medical Instrument Co., Ltd.
SKU: 2174332045

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

US$68,000.00

1-49 Sets

US$18,000.00

50+ Sets

Sample price:US$70000.00/set.Request sample

Product profile

Customization

Available

Classification

Imaging Diagnostic Equipment

Type

4K Endoscope Camera System

Model NO.

TK4K-1

Certification

Group

Endoscopic Surgery

Transport Package

Carton or Wooden Case

Specification

32 inches

Trademark

Origin

China

HS Code

8525811000

Production Capacity

10000 Per Year

Key features

Ultra HD 4K Imaging: Provides 3840x2160P resolution with 1500TVL and 50dB signal-to-noise ratio for clear diagnostics.

CE & FDA Certified: Meets strict safety standards with CE, FDA 510K, and ISO13485:2016 certifications.

IPX8 Waterproof Camera: The 4K camera head features IPX8 waterproof rating for safe sterilization and reuse.

20 Years Manufacturing: Factory with 20 years experience, 700+ patents, and exports to 40+ countries.

Flexible Customization: Offers OEM/ODM services including full customization from designs or samples.

Advanced Connectivity: Equipped with HDMI 2.0, DVI, and 4x12G-SDI outputs for versatile system integration.

Professional Support: Factory audits accepted with proven track record of passing US FDA on-site audits.

High Efficiency Production: 100% finished product inspection ensures quality with fast lead times within 15 days.

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: ≤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:Are you a factory or trading company?

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?

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: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.

Q: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. Please do not hesitate to contact me, I am always here waiting for assisting you!

Q:What is the video resolution of the endoscopy camera?

The camera supports Ultra HD 3840x2160P resolution with a scanning system of progressive scan and 60fps image rate.

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Endoscopy Camera 4K Equipment CE Certificate Without Trolley