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PNG New Model Floor Style 400tests Speed Auto Biochemistry Analyzer
Negotiable
1 Piece

Product profile

Customization

Available

Classification

Biochemical Apparatus

Type

Biochemistry Analyzer

Model NO.

HD-F4010

Certification

CE, FDA, MSDS, ISO13485

Group

Middle-aged and Old

Colorimetric Method

Direct Photometry in Cuvette

Test Speed

400tests/Hr

Test Method

End Point,Rating ,Double Wavelength

Test Item

40 Items Chemistry Test Plus 5 Items Electrolyte

Sample Tray

60sample Positions

Reagent Tray

80reagent Positions,Two Trays to Save Time

Reagent Volume

1-400UL

Reaction Time

0-900s

Reaction Temperature

37℃ ±0.2℃

Mixing Function

Independent Mixing Arms

Transport Package

Standard Packaging

Specification

CE SGS ISO9001 ISO13485 FDA

Trademark

HEPO

Origin

China

HS Code

9027809900

Production Capacity

3000 Sets Per Month

Company profile

Business Type: Manufacturer/Factory, Trading Company, Group CorporationAverage Response Time: ≤3.19h

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.

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