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CE Marked Home Rapid Test Kit Antigen Self Diagnostic Kit
Negotiable
3,000 Pieces
Sample price:US$2.50/piece.Request sample
Product profile
Customization
AvailableCertificate
CE, ISOTransport Package
Box+CartonModel NO.
Antigen TestTrademark
OBM/OEMOrigin
ChinaHS Code
3002150090Production Capacity
5, 000, 000 Pieces/MonthKey features
High Diagnostic Accuracy: Sensitivity of 96.64% and Specificity of 99.10% for reliable results.
Rapid Reaction Time: Delivers results within 15-20 minutes for quick self-diagnosis.
CE and ISO Certified: Meets international safety and quality standards with CE and ISO certificates.
Flexible Customization: Offers full, minor, and sample-based customization options for designs.
GMP Compliant Production: Manufactured in a 10,000 sqm GMP workshop meeting FDA, CE, and CFDA standards.
Strong R&D Capability: Led by experts from top universities with over 50% R&D personnel.
Fast Lead Time: Average production lead time is within 15 workdays for all seasons.
Company profile
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: 7 Years CertifiedNearest Port: Shanghai PortAverage Response Time: ≤15h
AI-Powered supplier vetting
SummaryJiangsu Medomics Medical Technology Co., Ltd. is an innovation-oriented medical-device enterprise in Nanjing engaged in the production and sale of biological and laboratory reagents, consumables, instruments, equipment, and medical devices. The supplier demonstrates broad customization and ODM capabilities, recent new-product development, OEM experience for well-known brands, raw-material traceability, and documented corrective-action and complaint-handling procedures. Its products are developed under ISO 13485 and have European CE certification. Service strengths include stocked inventory, stated lead times within 15 workdays in both peak and off-season periods, and participation in Medlab Middle East. Limitations include no valid manufacturing contract with related subcontractors, no overseas warehouse, showroom, agent, or branch, no overseas-service countries reported, and no available SDK. Financial credibility cannot be assessed from the provided information.
Supplier typeThe supplier is identified as a high-tech medical-device enterprise involved in R&D, production, and sales. Its stated business scope also covers biological and laboratory reagents, consumables, instruments, and equipment, subject to required regulatory approvals for applicable projects.
CertificationsThe supplier states that its product series were developed according to the ISO 13485 quality system and have European CE certification. This is explicit evidence of relevant quality-system and product-certification coverage.
After-Sales capabilityDocumented procedures and records exist for corrective and preventive actions and customer complaint handling. The supplier also reports inventory capability and lead times within 15 workdays in both peak and off-season, but has no overseas warehouse, showroom, agent, or branch and reports service coverage in zero countries.
R&D capabilityThe supplier reports new products during the past year, ODM capability, broad design and customization support, and an innovation-driven medical-device R&D profile. It also reports 42 years of total R&D-engineer experience, while no SDK is available; overall evidence supports strong product-development capability, with SDK capability specifically absent.
Production capacityEvidence includes production and sales operations, an automated processing line, raw-material traceability, four quality-assurance and quality-control inspectors, random finished-product inspection, stocked inventory, and stated lead times within 15 workdays. However, the supplier reports no valid manufacturing contract with its related subcontractors, which is a documented production-management weakness.
Customization capabilityThe supplier explicitly supports customization from samples, designs, full customization, minor customization, and flexible customization, and also provides ODM services. These statements directly demonstrate broad customization coverage.
Client casesThe supplier reports OEM service for well-known brands and participation in the Medlab Middle East offline trade show. These indicate some market-facing experience, but no specific customer names, project descriptions, order histories, or verifiable case details are provided.
Product Q&A
Q:What are the sensitivity and specificity rates?
A:
The kit features a sensitivity of 96.64% and a specificity of 99.10%.
Q:How long does it take to get results?
A:
The reaction time is between 15 to 20 minutes.
Q:Is customization available for this product?
A:
Yes, we offer full, minor, sample-based, and design-based customization options.
Q:What is the minimum order quantity?
A:
The minimum order quantity is 1 set.
Q:What certifications does the product hold?
A:
The product is CE marked and ISO certified.
Send Inquiry
*To:
Jiangsu Medomics Medical Technology Co., Ltd.
Jiangsu Medomics Medical Technology Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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