ISO13485 Approved Portable 12 Lead 3 Channel ECG Machine

Name: ISO13485 Approved Portable 12 Lead 3 Channel ECG Machine
Brand: Dawei Medical Co., Ltd
SKU: 2081995255

Jiangsu, ChinaDawei Medical Co., Ltd

US$369.00-699.00

1 Piece

Sample price:US$429.00/piece.Request sample

Product profile

Customization

Available

Classification

Biological Diagnostics

Type

ECG

Model NO.

DE 03

Certification

CE, FDA, MSDS, ISO13485

Group

for All Age Groups

Function

3 Channel/6 Channel/12 Channel 7 Inch Touch Screen

Transport Package

Export-Dedicated Paperboard Boxes

Specification

390mm× 300mm× 215mm

Origin

China

Production Capacity

20000/Year

Company profile

High Repeat Buyers ChoiceYears of Export ExperienceManagement CertificationSDK Available

Dawei Medical Co., Ltd

Jiangsu, 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.Export Year: 2016-07-01Nearest Port: shanghai, shenzhenAverage Response Time: ≤6.72h

AI-Powered supplier vetting

SummaryThe supplier demonstrates medical-device production and sales scope, product design and R&D capabilities, and broad customization services. It reports ISO13485:2012, European CE certification, Chinese medical-device registration certificates, three R&D centers, more than 100 patents and independent intellectual property rights, ODM and OEM services, and available SDK support. Quality processes include seven inspectors, documented finished-product inspection instructions, supplier-service procedures, corrective and preventive actions, and complaint-handling procedures. The supplier has exported goods for 19 years and reports lead times within 15 working days in both peak and off-season periods. However, it has no overseas warehouse, showroom, agent or branch, and reports zero countries with overseas services. Digitalization evidence is inconsistent: ERP use is reported, while another slice states that enterprise digital-process construction has not yet started. Financial credibility and customer cases...

Supplier typeThe stated business scope covers sales and production of Class I medical devices, sales of Class II medical devices, and manufacturing and sales of specialized veterinary instruments and machinery. This identifies the supplier as a medical-device and veterinary-equipment manufacturer and seller.

CertificationsThe supplier states that it has passed ISO13485:2012 quality-system certification and European CE quality certification, and that all products have obtained Chinese medical-device registration certificates. These are explicit certification and registration claims supporting this field.

R&D capabilityThe supplier reports new products during the past year, three technology R&D centers in Shanghai, Shenzhen and the United States, more than 100 patents and independent intellectual property rights, ODM services, OEM services for well-known brands, and an available SDK. These claims explicitly support substantial R&D and innovation capability.

Production capacityThe supplier states that it produces Class I medical devices and specialized veterinary instruments and machinery, operates an assembling line, uses seven quality assurance and quality-control inspectors, and follows written finished-product inspection instructions. It also reports ERP use for production, procurement, quality control and logistics, although another record says enterprise digital-process construction has not yet started, creating uncertainty about the broader digitalization status.

Customization capabilityThe supplier explicitly offers customization from samples, customization from designs, full customization, minor customization and flexible customization, together with 3D software design services. The same customization options are recorded in both the R&D and design-service information.