What certifications does the YSTE-BGS400 hold?

The device is certified with CE and ISO13485, ensuring it meets international standards for medical equipment quality and safety.

Yste-Bgs400 Medical Device Automated Blood Grouping Machine

Name: Yste-Bgs400 Medical Device Automated Blood Grouping Machine
Brand: Guangzhou Yueshen Medical Equipment Co., Ltd.
SKU: 2234394535

Guangdong, ChinaGuangzhou Yueshen Medical Equipment Co., Ltd.

Negotiable

1 Piece

Product profile

Customization

Available

Type

Automated Blood Grouping System

Certification

CE, ISO13485

Model NO.

YSTE-BGS400

Group

All

Name

Automated Blood Grouping Machine

Applications

Forward and Reverse Abo Blood Groupi

Microcolumn Gel Card Method

Accurate Result, Simple Operation, High Sensitivit

Strong Processing Ability

Batch Input of Patient Information, Batch Sample T

Intuitive Raw Image Results

CCD Digital Imaging, The Original Image Results Ca

Strong Data Management

Support a Variety of Bar Code Automatic Scanning a

Operation System

Supports Lis with Hospitals/Blood Stations, Manual

Transport Package

Standard Package

Specification

ISO

Trademark

Yueshen

Origin

China

Production Capacity

500 Units/ Year

Key features

Microcolumn Gel Card Method: Ensures accurate results, simple operation, and high sensitivity for detecting low antigen/antibody content.

CCD Digital Imaging: Provides intuitive raw image results that can be permanently stored, queried, and traced for reliability.

Strong Data Management: Supports barcode scanning, emergency sample priority, and flexible card placement for efficient workflow.

LIS System Integration: Seamlessly connects with hospital or blood station LIS for automatic result acquisition and error notification.

High Processing Efficiency: Enables batch input of patient information and batch sample test processing across multiple modules.

CE and ISO13485 Certified: Meets international quality and safety standards for medical devices, ensuring compliance and trust.

Company profile

Guangzhou Yueshen Medical Equipment Co., Ltd.

Guangdong, China

Business Type: Manufacturer/Factory, Trading CompanyExport Year: 2003-01-01Nearest Port: guangzhouAverage Response Time: ≤11.57hTerms of Payment: LC, T/T, Western Union, etc.International Commercial Terms(Incoterms): FOB, EXW, CFR, CIF, CIP, CPT, FCA

AI-Powered supplier vetting

SummaryGuangzhou Yueshen Medical Equipment Co., Ltd. is a privately owned Chinese supplier identified as both a trading company and manufacturer/factory. It reports ISO 9000 and ISO 13485 certification, five production lines, fewer than five quality-control staff, and 21–50 total staff experience. The company states that 90% of sales are exports, with export activity beginning in 2003, coverage across multiple global regions, and order lead times within 15 working days in both peak and off-peak seasons. It describes an established after-sales service team and recognition as a nationwide medical-device after-sales service advanced unit. Evidence of R&D experience exists, but the provided information does not establish product innovation outcomes or customization capability. Historical customer cases include substantial medical X-ray and surgical-instrument orders and cooperation with customers from 88 countries.

Supplier typeThe supplier is identified as a factory, as well as a trading company and manufacturer/factory, with its physical factory located in Guangzhou. Its stated business areas include medical equipment and manufacturing-related categories, supporting classification as a manufacturer-trader rather than only an intermediary.

CertificationsThe supplier reports holding ISO 9000 and ISO 13485 management-system certifications. ISO 13485 is specifically relevant to medical-device quality management, providing explicit evidence of certification aligned with its industry.

After-Sales capabilityThe company states that it has an established after-sales service team and describes this team as providing backup support to customers. It also reports being granted the nationwide Medical Device After-sale Service Advanced Unit designation, which is direct evidence supporting after-sales capability.

Production capacityThe supplier reports five production lines, a Guangzhou factory, fewer than five quality-control staff, and order fulfillment within 15 working days during both peak and off-peak seasons. Its stated export history includes 125 medical X-ray machines shipped to Congo in one operation, indicating demonstrated production and fulfillment experience, although the limited quality-control staffing is a constraint.

Client casesDocumented examples include exporting 125 medical X-ray machines to Congo in 2006 and a 2008 repeat order for 150 X-ray units and 800 sets of surgical instruments. The supplier also states that it has established cooperation with customers from 88 countries, indicating substantial international case experience.

Product Q&A

Q:What testing methods does the YSTE-BGS400 support?

It supports forward and reverse ABO blood grouping, Rh(D) and irregular antibody screening, and cross matching using the microcolumn gel card method.

Q:How does the system ensure result accuracy and traceability?

It uses CCD digital imaging to capture intuitive raw image results that can be permanently stored, queried, and traced for reliability.

Q:Can the machine integrate with hospital information systems?

Yes, it supports LIS integration with hospitals or blood stations, allowing for automatic acquisition, transmission, and error notification of test results.

Q:What are the key advantages of the microcolumn gel card method used?

It offers accurate results, simple operation, high sensitivity, and the ability to detect low content antigens and antibodies.

Q:How does the device handle batch processing and data management?

It features strong processing ability for batch sample tests, supports barcode scanning, and allows flexible card placement with emergency sample priority.