Ce Mark Clinical Diagnosis 12 Channels Digital Electrocardiograph

Name: Ce Mark Clinical Diagnosis 12 Channels Digital Electrocardiograph
Brand: Zhengzhou Hepo International Trading Co., Ltd.
SKU: 770276275

Henan, ChinaZhengzhou Hepo International Trading Co., Ltd.

US$850.00

1-4 Pieces

US$630.00

5+ Pieces

Product profile

Customization

Available

Classification

Physiological Functions of Diagnosis and Monitoring Equipment

Type

ECG

Model NO.

3312G

Certification

CE, FDA, EEC, ISO13485

Group

Middle-aged and Old

Lead

Standard 12 Leads

AC Filter

50Hz/60Hz

Emg Filter

25Hz/45Hz

Auti-Drift Filter

0.15Hz (Adaptive)

Sensitivity

5,10,20mm/Mv

Paper Speed

25,50mm/S(&Plusmn3%)

Communication

RS232 Port, USB

Dimension/Weight

330X270X70mm/3.8kg

Transport Package

Wooden Package

Specification

ISO9001: 2008 ISO13485 CE SGS

Trademark

hepomed

Origin

China

Production Capacity

350 PCS/Month

Company profile

Zhengzhou Hepo International Trading Co., Ltd.

Henan, China

Business Type: Manufacturer/Factory, Trading Company, Group CorporationAverage Response Time: ≤1.80h

AI-Powered supplier vetting

SummaryThe supplier presents established manufacturing and quality-system credentials, with eight production lines, stated output across five medical-equipment categories, broad export coverage, and ISO 13485, ISO 9001, ISO 14001, and GMP certifications. It offers extensive product customization and maintains inventory capability, with stated lead times within 15 working days in both peak and off-season periods. However, evidence also shows material gaps: no written corrective-action or complaint-handling procedures, no documented service-assessment procedure, no environmental impact assessment report, no overseas warehouse or showroom, no recent new-product activity, no ODM or major-brand OEM service, no SDK, zero stated R&D patents, and no available R&D design-control documentation. Financial records are indicated for multiple years, but the slices do not provide sufficient non-financial evidence to assess financial credibility.

Supplier typeThe supplier manufactures medical and biosafety-related equipment, including cold-chain, clinical, first-aid, and laboratory products. It operates eight production lines, describes imported production equipment, and exports to multiple global regions, indicating a manufacturer with broad product and market coverage.

CertificationsThe supplier states that its factories adopted ISO 9001:2008 and ISO 13485 systems, while its supplier-management certifications include ISO 13485, ISO 9001, ISO 14001, and GMP. These explicitly stated certifications support a positive assessment of formal quality and management-system coverage.

R&D capabilityThe supplier has 11–20 years of total R&D-engineer experience and can customize products, but reports no new products during the past year, no SDK, no software-instrument R&D, zero R&D patents, and no available design-input, output, review, verification, or validation documentation. The explicit evidence indicates limited demonstrated innovation infrastructure.

Production capacityThe supplier operates eight production lines and reports production quantities for deep freezers, analyzers, and incubators, alongside inventory capability and broad export markets. Its company description also cites dedicated product solutions and imported production equipment, providing explicit evidence of substantial manufacturing capability.

Customization capabilityThe supplier explicitly offers customization from samples and designs, full, minor, and flexible customization, and assigns R&D engineers to customize products according to customer needs. However, the absence of documented R&D design-control records means process formalization is not demonstrated, while the customization offering itself is clearly supported.