What certifications does the product have?

The product holds CE and ISO13485 certifications.

Bone Cement Spinal Surgery Kyphoplasty System Tool

Name: Bone Cement Spinal Surgery Kyphoplasty System Tool
Brand: Euro-Tek Industrial Co., Ltd.
SKU: 2029069155

Jiangsu, ChinaEuro-Tek Industrial Co., Ltd.

US$198.00-205.00

1 Piece

Sample price:US$198.00/piece.Request sample

Product profile

Customization

Available

Type

Cement Injector

Application

Orthopedic, Microsurgery

Model NO.

TY-BCI-316

Material

Pure Titanium

Feature

Disposable

Certification

CE, ISO13485

Group

Adult

Properties

Orthopedic Surgical Instruments

Instrument Classification

Class II

Warranty

One Year

After-Sale Service

Online Technical Support

Package

Sterile/Non-Sterile Package

Color

as Picture

Certificate

CE/ISO 13485

Transport Package

Carton

Trademark

Inature, AND

Origin

Jiangsu, China

HS Code

9021100000

Production Capacity

5000 Sets/Month

Key features

CE & ISO13485 Certified: Complies with CE and ISO13485 standards for medical instrument safety and quality.

Pure Titanium Material: Constructed from pure titanium for durability and biocompatibility in orthopedic surgery.

Lifetime Maintenance Support: Provides timeless maintenance service and technical guidance for all product issues.

Flexible Customization: Offers full, minor, and flexible customization options from samples or designs.

1-Year Repair Warranty: Includes free repair services within one year for non-operator-caused defects.

Disposable Design: Designed as a disposable cement injector for single-use orthopedic applications.

Company profile

High Repeat Buyers ChoiceImporters and ExportersYears of Export ExperienceExperienced Team

Euro-Tek Industrial Co., Ltd.

Jiangsu, China

CertifiedBusiness Type: Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 21Years CertifiedNearest Port: Shanghai PortAverage Response Time: ≤5.57h

AI-Powered supplier vetting

SummaryThe supplier is identified as a professional technical supplier and also described as a trading company, with its company district in Zhangjiagang, Jiangsu, China. It holds ISO 13485 and ISO 9001 certifications, and its products reportedly passed SFDA quality-system certification; some products also obtained CE certification. R&D evidence includes new products in the past year, ODM services, OEM services for well-known brands, approximately 50 years of combined R&D-engineer experience, and extensive customization options. Production evidence includes more than 10 production lines, 11–20 quality-control staff, and broad export coverage. However, the supplier does not provide 3D software design, SDKs, inventory, overseas warehouses, overseas showrooms, or overseas agents/branches. After-sales and quality-assurance procedures are insufficiently specified, and no explicit customer names or case details are provided. Financial records are referenced for 2023–2025, but their results are not disclosed.

Supplier typeThe supplier is explicitly classified as a professional technical supplier, while the company-type information identifies it as a trading company located in Zhangjiagang, Jiangsu, China. This indicates technical-service positioning but also a trading-company structure; the slices do not establish whether it owns manufacturing facilities.

CertificationsThe supplier reports ISO 13485 and ISO 9001 management-system certifications. Its description also states that products passed SFDA quality-system certification and that some products obtained CE certification, providing explicit evidence of relevant quality and compliance credentials.

R&D capabilityThe supplier reports new products within the past year, ODM and OEM capabilities, and approximately 50 years of combined R&D-engineer experience. However, it does not provide an SDK or 3D software design services, limiting evidence for software-related innovation.

Production capacityProduction-related evidence includes more than 10 production lines, 11–20 quality-control staff, broad export markets, and lead times within 15 workdays in both peak and off-season. The stated production scale supports a positive assessment, although the supplier is also classified as a trading company and ownership of the listed production resources is not explicitly confirmed.

Customization capabilityThe supplier explicitly offers customization from samples, designs, full customization, minor customization, and flexible customization. Its ODM and OEM services further support the conclusion that it can handle multiple product-development and customization requirements.