What is the certification for this device?

The equipment is certified under ISO13485 standards.

Yste1020 Hospital Medical Laboratory Fully Automatic Chemistry Analyzer

Name: Yste1020 Hospital Medical Laboratory Fully Automatic Chemistry Analyzer
Brand: Guangzhou Yueshen Medical Equipment Co., Ltd.
SKU: 835198535

Guangdong, ChinaGuangzhou Yueshen Medical Equipment Co., Ltd.

Negotiable

1 Set

Product profile

Customization

Available

Classification

Biochemical Apparatus

Type

Biochemistry Analyzer

Model NO.

YSTE1020

Certification

ISO13485

Group

All

Equipment Type

Fully Automatic Discrete, Stat Priority

Analysis Rate

Constant Speed 200t/H (Without ISE)

Test Principle

Colorimetry, Turbidimetry

Sample Tray

42 Sample Positions, Random Access of All Samples

Sample Volume

2-50UL, 0.1UL Increment

Reagent Tray

25 Reagent Positions

Reagent Volume

R1:25-300UL, R2:10-150UL, 0.1UL Increment

Reaction Tray

Rotating Tray, 120 Cuvettes

Reaction Volume

180-500UL

Temperature

37℃±0.1℃ with Real-Time Display

Transport Package

Wooden Carton

Specification

CE certificate

Trademark

YSENMED

Origin

Guangzhou

Production Capacity

1, 000 Sets / Year

Key features

High Analysis Rate: Constant speed 200 tests per hour without ISE module.

Random Sample Access: 42 sample positions allow random access to all samples.

Multi-Wavelength Detection: Supports 8 specific wavelengths from 340nm to 700nm.

Comprehensive Safety Features: Probe includes liquid level, remaining detection, and collision protection.

Flexible Calibration Support: Supports single/double wavelength, linear and non-linear calibration.

ISO13485 Certified: Meets international quality standards for medical devices.

Company profile

Guangzhou Yueshen Medical Equipment Co., Ltd.

Guangdong, China

Business Type: Manufacturer/Factory, Trading CompanyExport Year: 2003-01-01Nearest Port: guangzhouAverage Response Time: ≤11.18hTerms 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.