What certifications does the product have?

It holds CE, ISO13485, and FDA certificates.

What is the low sperm count threshold?

Low sperm count is defined as fewer than 15 million sperm per milliliter.

Ivd Sperm Concentration Male Fertility Self Tests

Name: Ivd Sperm Concentration Male Fertility Self Tests
Brand: Henan Season Medical Device Co., Ltd.
SKU: 1914560676

Henan, ChinaHenan Season Medical Device Co., Ltd.

US$1.30

10,000-49,999 Pieces

US$1.20

50,000-99,999 Pieces

US$1.10

100,000+ Pieces

Sample price:US$0.10/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Accuracy

99.2%

Model NO.

SP-1012

Sensitivity

98.1%

Specimen

Sperm

Format

Strips, Cassettes, Midstreams

Certificate

CE0123

Specificity

99.5%

Transport Package

Carton

Origin

Hangzhou

HS Code

3822190090

Production Capacity

3000000PCS/Day

Key features

High Accuracy Rate: Achieves 99.2% accuracy for reliable sperm concentration results.

High Sensitivity: Features 98.1% sensitivity to detect low sperm counts effectively.

Fast Reading Time: Provides results within 5 minutes for quick self-assessment.

Multiple Formats Available: Offered in Strip, Cassette, and Midstream formats to suit user needs.

Global Certifications: Certified with CE, ISO13485, and FDA standards for quality assurance.

Long Shelf Life: Valid for 24 to 36 months ensuring product stability.

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

Complete Kit Contents: Includes cassette, dropper, staining solution, workstation, and collection cup.

Company profile

Henan Season Medical Device Co., Ltd.

Henan, China

Business Type: Manufacturer/FactoryExport Year: 2005-08-05Nearest Port: Shanghai, TIANJINAverage Response Time: ≤6.91hTerms 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.