What certifications does the device have?

The device holds CE, FDA, EEC, MSDS, and ISO13485 certifications.

Smart Blood Coagulation Analyzer for Enhanced Medical Diagnostics

Name: Smart Blood Coagulation Analyzer for Enhanced Medical Diagnostics
Brand: Somatech Medical Co., Ltd.
SKU: 2257227625

Sichuan, ChinaSomatech Medical Co., Ltd.

US$3,000.00-4,250.00

1 Piece

Product profile

Customization

Available

Classification

Physiological Functions of Diagnosis and Monitoring Equipment

Type

Hematology Analyzer

Model NO.

st-xl000c

Certification

CE, FDA, EEC, MSDS, ISO13485

Group

Specific Population

Warranty

1 Year

After-Sale Service

Online Technical Support

Application

Laboratory, Hospital

Material

Metal, Plastic

Reagent Positions

6~11

Test Item 1

Aptt, Tt, PT, Fib and Blood Coagulation Factors

Transport Package

Standard Package

Specification

40X34X18 cm

Trademark

Soma Tech

Origin

Mianyang City Sichuan Province

HS Code

9018121000

Production Capacity

1200/Year

Key features

High Precision & Speed: Test speed up to 100Ts/h with high precision optical coagulation method.

Advanced Interference Removal: Background scan removes jaundice and high fat interference for accurate results.

Smart Safety Alarms: Features alarms for insufficient reagents, waste overflow, and abnormal results.

Reagent Preservation: Tilt and refrigerated reagent positions ensure full utilization of reagents.

Certified Quality: CE, FDA, EEC, and ISO13485 certified with 100% pre-delivery testing.

Low Operating Cost: Designed for small customers with lower operating costs and high efficiency.

User-Friendly Design: LED lighting system and constant temperature heating for accurate measurements.

Company profile

Importers and ExportersODM ServicesManagement CertificationQuality Assurance

Somatech Medical Co., Ltd.

Sichuan, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 10 Years CertifiedNearest Port: Shanghai PortAverage Response Time: ≤3.85h

AI-Powered supplier vetting

SummaryThe supplier produces, sells, and services Class II 6823 medical ultrasound instruments and related equipment, with additional mechanical and electronic product activities. It demonstrates broad customization, ODM availability, SDK support, recent new-product activity, raw-material traceability, 100% finished-product inspection, and documented corrective-action and complaint-handling procedures. Manufacturing includes three production lines and inventory capability, but the supplier lacks a valid manufacturing contract with related subcontractors, has no overseas agents, branches, warehouse, or showroom, and reports no overseas-service countries. Certification details are insufficiently specific, financial credibility cannot be assessed from the provided information, and no evidence of cooperation with major brands or Fortune 500 companies is provided.

Supplier typeThe supplier’s stated business scope covers production, sales, and services for Class II 6823 medical ultrasound instruments and related equipment, along with mechanical and electronic products and import/export activities. This supports classification as a medical ultrasound equipment manufacturer and service supplier.

After-Sales capabilityThe supplier has documented procedures and records for corrective and preventive actions and customer complaints, offers inventory capability, and has participated in Arab Health 2025. However, it has no overseas agents or branches, overseas warehouse, overseas showroom, or stated overseas-service countries, limiting the evidence for broad international after-sales coverage.

R&D capabilityThe supplier reports new products during the past year, ODM services, an available SDK, four R&D engineers, and one national science and technology progress award. These explicit indicators support active R&D and product-development capability.

Production capacityProduction evidence includes three production lines, four quality inspectors, 100% finished-product inspection, quality assurance, and inventory capability. However, the supplier lacks a valid manufacturing contract with related subcontractors, does not continuously reconcile production quantities for each batch, and has no outsourcing SOP, creating documented production-control weaknesses.

Customization capabilityThe supplier explicitly provides customization from samples, customization from designs, full customization, and minor customization, and also offers ODM services. The repeated evidence indicates broad customization coverage.

Client casesThe supplier reports no cooperation with Fortune 500 companies and no OEM service for popular brands. Although repeat-buyer preference is stated at 50%–80%, no identifiable customer names or documented customer cases are provided.