What certifications does the product have?

The product is certified under ISO13485.

My-B031A Laboratory Blood Coagulation Single Test Channel Coagulometer Analyzer

Name: My-B031A Laboratory Blood Coagulation Single Test Channel Coagulometer Analyzer
Brand: Guangdong Maikang Medical Co., Ltd.
SKU: 2252719425

Guangdong, ChinaGuangdong Maikang Medical Co., Ltd.

US$660.00

1-9 Pieces

US$640.00

10+ Pieces

Product profile

Customization

Available

Certification

ISO13485

Keyword

Coagulometer

Model NO.

MY-B031A

Channel

Single Test Channel

Color

White

MOQ

Transport Package

Coagulometer Packing

Trademark

MAYAMED

Origin

China

Key features

Large Data Storage: Capable of restoring up to 10,000 testing results.

Comprehensive Test Coverage: Performs PT, APTT, TT, Fibrinogen, and clotting factors.

ISO13485 Certified: Meets international medical device quality management standards.

Flexible Customization: Offers full, minor, and sample-based customization options.

Integrated Printing: Features an inner thermal-sensitive printer for immediate reports.

Sample Pre-warm System: Includes 6 sample pre-warm positions for optimal testing conditions.

Company profile

Years of Export ExperienceExhibition ExperienceIn-stock CapacityPrivate Mold

Guangdong Maikang Medical Co., Ltd.

Guangdong, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 12 years CertifiedNearest Port: Guangzhou Port, Shenzhen PortAverage Response Time: ≤5.91h

AI-Powered supplier vetting

SummaryThe supplier is a combined company with over 10 years of experience, reported exports to more than 100 countries, and stated concentration in African, Middle Eastern African, and South American markets. It demonstrates broad customization, active R&D, ODM and OEM capabilities, R&D documentation, and production of medical equipment at 100,000 pieces annually. Manufacturing resources include three production lines, listed processing equipment, valid contracts with associated subcontractors, and in-stock capacity. Service management procedures cover supplier assessment, corrective and preventive actions, and customer complaints. However, the evidence does not establish certification holdings, and the supplier reports no R&D patents, no SDK, no overseas warehouse, no overseas showroom, and no overseas agents or branches. Financial credibility cannot be determined from the provided year references alone. Customer-case evidence is limited to general export and brand-service claims without named customers or...

After-Sales capabilityThe supplier states that it has an after-sale service office in Lagos, Nigeria and Madagascar, while also maintaining written and followed procedures for customer complaints and service corrective actions. However, another record states it has no overseas agents or branches and lists overseas service offerings as training, so the overall overseas service structure is inconsistently documented.

R&D capabilityThe supplier reports new products within the past year, ODM capability, and auditable R&D design-input, output, review, verification, and validation documentation. It has two R&D engineers and uses PS and CAD, but reports zero patents and no available SDK, indicating documented product-development capability without evidence of patent-based innovation or SDK support.

Production capacityThe supplier reports annual medical-equipment output of 100,000 pieces, three production lines, listed machining and production equipment, in-stock capacity, and valid manufacturing contracts with associated subcontractors. These statements provide explicit evidence of established production capacity.

Customization capabilityBoth R&D and design-capability records list customization from samples, designs, full customization, minor customization, and flexible customization. This directly supports a broad range of customization services.