What certifications does the product have?

The product holds CE and ISO13485 certifications.

Home Use Bacterial Vaginosis BV Rapid Diagnostic Test for pH

Name: Home Use Bacterial Vaginosis BV Rapid Diagnostic Test for pH
Brand: Henan Season Medical Device Co., Ltd.
SKU: 1914600906

Henan, ChinaHenan Season Medical Device Co., Ltd.

US$1.44

10,000-49,999 Pieces

US$1.34

50,000-99,999 Pieces

US$1.24

100,000+ Pieces

Sample price:US$0.10/piece.Request sample

Product profile

Customization

Available

Type

Test Strips & Test Tube

Material

Plastic

Model NO.

SV-1006

Ethylene Oxide Sterilization

Quality Guarantee Period

Two Years

Group

Adult

Logo Printing

with Logo Printing

Accuracy

98.6%

Sensitivity

95%

Specimen

Stool

Format

Cassettes

Product

Vaginal pH Test Kits

Specificity

99%

Transport Package

Carton

Trademark

Origin

Hangzhou

HS Code

3822190090

Production Capacity

300000PCS/Day

Key features

High Accuracy: Accuracy exceeds 98.6% for reliable diagnostic results.

Fast Results: Read results within 5 minutes for immediate assessment.

CE Certified: Certified under CE and ISO13485 standards for quality assurance.

User Friendly: Designed for laymen to perform tests easily and privately.

OEM Service: OEM production available with a lead time of 20 days.

High Sensitivity: Sensitivity rate of 95% ensures effective detection.

High Specificity: Specificity rate of 99% minimizes false positive results.

Company profile

Henan Season Medical Device Co., Ltd.

Henan, China

Business Type: Manufacturer/FactoryExport Year: 2005-08-05Nearest Port: Shanghai, TIANJINAverage Response Time: ≤6.06hTerms of Payment: T/T, PayPal, Western Union, etc.International Commercial Terms(Incoterms): FOB, EXW, CFR, CIF, DDP, DAP, FCA

AI-Powered supplier vetting

SummaryHenan Season Medical Device Co., Ltd. is identified as a Chinese manufacturer/factory specializing in point-of-care and in-vitro diagnostic self-testing products. The supplier reports eight production lines, annual Early Pregnancy HCG test output of 10,000,000 pieces, and lead times of within 15 working days in both peak and off-peak seasons. Its stated export coverage is broad, with exports accounting for 90% of total sales. ISO 9001, ISO 13485, ISO 14001, and CE/FDA-related approvals are reported. Evidence also indicates OEM packaging, R&D engineers, and quality-control staff. However, the provided information does not sufficiently establish after-sales service processes, financial credibility, or verified customer case depth. Trade data shows only one transaction, which is insufficient to demonstrate an established customer track record.

Supplier typeThe supplier is explicitly identified as a Manufacturer/Factory and Limited Company based in Zhengzhou, Henan, China. Its stated business focuses on biomedical IVD and rapid self-testing products, indicating direct manufacturing involvement rather than only trading activity.

CertificationsThe supplier reports ISO 9001, ISO 13485, and ISO 14001 certifications or approvals, and states that its products have received CE approval in Europe and FDA approval in the United States. These claims provide explicit evidence of a certification and regulatory-compliance capability, although the slices do not provide certificate numbers, validity dates, or scope details.

R&D capabilityThe supplier reports 6–10 years of R&D engineer experience and offers a broad range of rapid and self-testing products, including digital pregnancy and ovulation tests, vitamin D, UTI, syphilis, and drug tests. This supports product-development capability, although no specific patents, new-product launches, or measurable innovation outcomes are provided.

Production capacityThe supplier reports eight production lines, annual Early Pregnancy HCG test output of 10,000,000 pieces, and order fulfillment within 15 working days during both peak and off-peak seasons. Its export sales share is reported as 90%, indicating stated production and international fulfillment experience.

Customization capabilityThe supplier explicitly offers OEM packaging and states that it provides customer-specific solutions and configurations. This supports packaging-level customization, but the slices do not confirm broader customization such as formulation, tooling, labeling compliance, or product design changes.