FDA CE Approved Medical Disposable Rapid Test Kit Vtm

Name: FDA CE Approved Medical Disposable Rapid Test Kit Vtm
Brand: Changsha Renji Medical Equipments Co., Ltd.
SKU: 1924656672

Hunan, ChinaChangsha Renji Medical Equipments Co., Ltd.

US$0.20-0.80

1,000 Pieces

Sample price:US$0.10/piece.Request sample

Product profile

Customization

Available

Type

Test Strips & Test Tube

Material

Plastic

Model NO.

SL901A

Ethylene Oxide Sterilization

High Energy Electron Beam Irradiation

Quality Guarantee Period

One Year

Group

All Ages

Logo Printing

With Logo Printing

Package Way

Individual or Bulk

Transport Package

Carton

Specification

22.5*14.5*16.5cm

Trademark

Renji

Origin

China

HS Code

3822009090

Production Capacity

100000000

Key features

FDA and CE Approved: Certified by FDA, CE, NMPA, ISO13485, and SGS for medical safety.

High Collection Efficiency: Nylon flocking swab achieves up to 95% collection and release rate.

Sterile and Safe: Sterilized via High Energy Electron Beam Irradiation for biological safety.

Durable ABS Handle: Flexible ABS handle prevents breakage and ensures user comfort.

Full Traceability: Lot number printed on each kit for complete specimen tracking.

Customizable Packaging: Available in individual or bulk packaging to save costs.

Versatile Application: Suitable for Influenza, Hand-Foot-Mouth, Measles, and other viral tests.

Company profile

Self-brandedStandardized quality controlR&D CapabilitiesManagement Certification

Changsha Renji Medical Equipments Co., Ltd.

Hunan, China

Business Type: Manufacturer/Factory, Trading CompanyExport Year: 2020-10-01Nearest Port: guangzhou, shenzhen, shanghaiAverage Response Time: ≤6.89hTerms of Payment: LC, T/T, D/P, etc.International Commercial Terms(Incoterms): FOB, CFR, CIF, FCA, EXW

AI-Powered supplier vetting

SummaryThe supplier is identified as a manufacturing factory producing sanitary materials, medical supplies, medical devices, disinfection products, and sanitary equipment. It reports customization from samples, designs, and full specifications, with two production lines and export markets spanning multiple regions. Quality and service procedures are documented, and the supplier states that it holds or has products approved by CE, SGS, ISO13485, NMPA, and ISO9001:2015-related certification. It also reports OEM service for known brands and experience exporting to more than 50 countries. However, no SDK is available, and the supplier lacks in-stock service, overseas warehouse, overseas showroom, and a valid manufacturing-capacity contract with affiliated subcontractors. Financial information is represented only by years rather than usable performance figures, so financial credibility cannot be determined.

Supplier typeThe supplier is explicitly identified as a factory, with a business scope covering manufacturing of sanitary materials, medical supplies, medical devices, disinfection products, and sanitary equipment. Its associated companies are classified in manufacturing, supporting a direct manufacturing-supplier profile.

CertificationsThe supplier reports an ISO9001:2015 certificate and states that its products have been approved by CE, SGS, ISO13485, and NMPA, among others. These stated certifications and approvals provide explicit evidence of certification coverage, although the slices do not provide certificate numbers, validity dates, or scope details.

After-Sales capabilityThe supplier reports written and followed procedures for service-capability assessment, corrective and preventive actions, and customer complaint handling. This is explicit evidence of a documented after-sales and complaint-management system.

R&D capabilityThe supplier explicitly reports no available SDK, which limits evidence of software-development or integration capability. Although it emphasizes product certifications and customer-oriented management, the slices do not establish broader research, product-development, or innovation performance.

Production capacityThe supplier operates two production lines, reports peak-season fulfillment of one month and off-peak lead time within 15 working days, and has export access through major Chinese ports. However, it reports no in-stock capacity and no valid manufacturing-capacity contract with affiliated subcontractors, creating explicit operational limitations despite its stated factory capacity.

Customization capabilityThe supplier explicitly offers customization from samples, designs, and full customization, and also reports OEM service for known brands. These capabilities directly support customized and OEM manufacturing requirements.

Client casesThe supplier states that it provides OEM services for known brands and has export experience involving more than 50 countries. These statements indicate brand-related and international customer experience, but no specific customer names, project details, or independently verifiable cases are provided.

Product Q&A

Q:Do you sell Swabs and/or solution separately?

Yes, we can sell any of the individual components in bulk.

Q:Can I customize my transport media?

If there is a specific formula or change that you would like to see, let us know and our team will review to make sure that we find the most efficient way possible to meet your needs.

Q:What information do you need from me to get started?

Let us know the specs of what you are looking for, the quantity, and any other requirements. Our team will work with you to make sure you get exactly what you need.

Q:Do you have any references?

We successfully supply many labs and health care systems in the space. If you'd like to view any of our references, we'd be happy to provide them.

Q:What are the lead times?

Lead times can vary depending on your need and freight availability. At the time of your order, a member of our team will provide you with the most accurate and current lead time.