Is this equipment classified as a Class II instrument?

Yes, the instrument classification is Class II, categorized under Medical X-ray Equipments & Accessories.

Dental CT Scan 3D Scanner Xray Digital Holder Panoramic 6500 Dentaire

Name: Dental CT Scan 3D Scanner Xray Digital Holder Panoramic 6500 Dentaire
Brand: Guangzhou Maya Medical Equipment Co., Ltd.
SKU: 1913134502

Guangdong, ChinaGuangzhou Maya Medical Equipment Co., Ltd.

US$53,000.00

1 Piece

Product profile

Customization

Available

Certification

CE, ISO13485

Scale

Large

Model NO.

MY-D065B

Voltage

AC220V ± 22V

Kv Range

40~110kv

Mas Range

0.2-200mas

Exposure Time

0.01s~4s

Properties

Medical X-ray Equipments & Accessories

Instrument Classification

Class II

Transport Package

Wooden Carton

Specification

Standard

Trademark

Mayamed

Origin

China

Production Capacity

500

Key features

CE & ISO13485 Certified: Meets international safety and quality standards for medical X-ray equipment.

OEM & ODM Services: Supports full customization from samples, designs, and minor adjustments.

Wide Kv Range: Operates within 40-110kv range for versatile dental imaging needs.

Fast Lead Time: Consistent delivery within 15 working days regardless of season.

100% Quality Inspection: Every unit undergoes strict visual and functional inspection before shipping.

Portable Design: Compact digital sensor positioner and holder for easy clinic mobility.

Flexible Exposure Control: Adjustable exposure time from 0.01s to 4s and MAS from 0.2-200mas.

Established Manufacturer: Factory established in 2011 with 31 employees and 3 production lines.

Company profile

Importers and ExportersYears of Export ExperienceExperienced TeamExhibition Experience

Guangzhou Maya Medical Equipment 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: 12 years CertifiedNearest Port: Guangzhou Port, Shenzhen PortAverage Response Time: ≤6.31h

AI-Powered supplier vetting

SummaryThe supplier is identified as a Guangzhou-based trading company with a combined company type, rather than explicitly as a manufacturer. It demonstrates broad customization, ODM and OEM capabilities, recent new-product activity, and documented R&D design review, verification, and validation records. Production-related evidence includes three production lines, 50 quality-control staff, inventory capability, contracted associated subcontractors, and lead times within 15 workdays in both peak and off-season periods. Export experience is established at 12 years, with 90% of sales from exports and self-operated import/export rights. However, no certifications, customer cases, overseas warehouses or showrooms, SDK availability, or R&D patents are documented. Financial information is present only as year references, without sufficient evidence to assess credibility.

After-Sales capabilityThe company description states that the team provides comprehensive after-sales service, and overseas service offerings include training. However, the supplier reports no overseas warehouse or showroom and lists zero countries for overseas services, so the scope of international support appears limited.

R&D capabilityThe supplier reports new products within the past year, provides ODM services, and maintains design input, output, review, verification, and validation documents available for audit. It uses PS and CAD, but has no available SDK and reports zero R&D patents, indicating documented development activity but limited evidence of proprietary innovation.

Production capacityThe supplier reports three production lines, 50 quality-control staff, inventory capability, valid contracts with each associated subcontractor, and average lead times within 15 workdays in both peak and off-season. Finished-product inspection follows written instructions uniformly, supporting a positive assessment of operational capacity and process control.

Customization capabilityBoth R&D and design-service records list customization from samples, designs, full customization, minor customization, and flexible customization. The supplier also reports ODM capability, providing explicit evidence of broad customization support.

Client casesThe supplier states that it provides OEM services for well-known brands, which is evidence of brand-related customer experience. No customer names, project details, order history, or verifiable case studies are provided, limiting assessment of the depth and relevance of those cases.