What certifications does the product have?

The product holds CE, FDA, and ISO13485 certifications.

Bk 18L5s (9081) Ultrasound Probe Linear Array Transducer for Bkspecto, Bk3000, 5000, Bkactiv

Name: Bk 18L5s (9081) Ultrasound Probe Linear Array Transducer for Bkspecto, Bk3000, 5000, Bkactiv
Brand: Shenzhen Reyardmed Technology Limited.
SKU: 2189519775

Guangdong, ChinaShenzhen Reyardmed Technology Limited.

US$1,000.00-5,000.00

1 Piece

Product profile

Customization

Available

Customized

Certification

CE, FDA, ISO13485

Model NO.

18L5s (9081)

Scale

Medium

Brand

Model

18L5s (9081)

Type

Linear

Frequency Range

18-5 MHz

Compatible Systems

Bkspecto, Bk3000, 5000, Bkactiv

Applications

Musculoskeletal, Pediatric, Peripheral Vascular

Materials

Metal, Pastics

Warranty

Six Months

Transport Package

Common Box

Origin

China

HS Code

9018129190

Production Capacity

50000PCS/Year

Key features

Broad System Compatibility: Compatible with Bkspecto, Bk3000, 5000, and Bkactiv ultrasound systems.

Multi-Application Support: Ideal for Musculoskeletal, Pediatric, Peripheral Vascular, and Urology procedures.

Global Certifications: Certified with CE, FDA, and ISO13485 for international safety and quality standards.

Customized Manufacturing: Offers customized options for brand, model, and specific clinical requirements.

High Frequency Range: Operates within 18-5 MHz frequency range for precise imaging resolution.

Comprehensive Warranty: Includes one-year warranty with replacement or refund options for defects.

Rapid Lead Time: Peak and off-peak season lead times are both within 15 workdays.

Expert Repair Services: ISO-certified repair center offering cost-effective servicing with 100% quality guarantee.

Company profile

Shenzhen Reyardmed Technology Limited.

Guangdong, China

Business Type: Trading CompanyAverage Response Time: ≤2.00h

AI-Powered supplier vetting

SummaryThe supplier is a limited trading company offering ultrasound probes and related medical-device, technology, rental, consulting, and trading services. It reports ISO 13485 certification, 11–20 years of combined R&D-engineer experience, 6–10 quality-control staff, broad export coverage, and order fulfillment within 15 working days in both peak and off-peak periods. However, it does not provide OEM services for popular brands or an SDK, and the available quality-control evidence identifies zero quality-control test equipment, no written corrective/preventive-action or complaint-handling procedures, and unknown quality-assurance and traceability status. Financial records are referenced for 2022–2024, but no usable financial performance figures are provided. Customer relationships across multiple regions are described, but no specific customer cases are named.

CertificationsThe supplier reports holding ISO 13485 certification, a medical-device quality-management certification. The slices do not provide the certificate number, validity period, certification scope, or product coverage, so the certification is evidenced but its applicability cannot be fully assessed.

After-Sales capabilityThe supplier describes support from pre-sales consultation through after-sales technical assistance and states that it serves hospitals, clinics, and distributors internationally. However, it also reports no written procedures or records for corrective and preventive actions or customer-complaint handling, which shows a documented service-process deficiency despite the stated support commitment.

Production capacityThe supplier offers ultrasound probes, reports an annual production-output range, exports to multiple regions, and states order fulfillment within 15 working days in both peak and off-peak seasons. Against these positive operational indicators, the quality-control slice reports zero quality-control test equipment and unknown quality-assurance and traceability status, creating a clear documented weakness in production-quality infrastructure.

Customization capabilityThe supplier lists technology development, consultation, exchange, transfer, and technical services, and has reported R&D-engineer experience. However, it explicitly does not provide OEM services for popular brands and has no available SDK; no other product-customization process or capabilities are documented.