What certifications does this product have?

The product holds CE, ISO13485, and FDA certifications.

How do I interpret a positive result?

If the test line is equal to or darker than the control line, it indicates an LH surge and ovulation is likely in 24-48 hours.

What is the lead time for orders?

The average lead time is within 15 working days for both peak and off-peak seasons.

CE&ISO13485 One Step Urine Lh Ovulation Urine Test Kits

Name: CE&ISO13485 One Step Urine Lh Ovulation Urine Test Kits
Brand: Henan Season Medical Device Co., Ltd.
SKU: 1916424576

Henan, ChinaHenan Season Medical Device Co., Ltd.

US$0.32

10,000-49,999 Pieces

US$0.30

50,000-99,999 Pieces

US$0.286

100,000+ Pieces

Sample price:US$0.10/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Accuracy

99.5%

Model NO.

SP-123

Sensitivity

25mlu/Ml, 10mlu/Ml

Specimen

Urine

Format

Strips, Cassettes, Midstreams

Certificate

CE0197

Product Name

Lh Ovulation Test

Transport Package

Carton

Trademark

Origin

Beijing

HS Code

3822190090

Key features

High Accuracy Rate: Accuracy exceeds 99.5% for reliable LH surge detection.

Fast Result Time: Results are available within 3 to 8 minutes of testing.

Multiple Formats Available: Offered in Strip, Cassette, and Midstream formats.

Long Shelf Life: Valid for 24 to 36 months when stored properly.

OEM Service: Customized OEM production available within 20 days.

International Certifications: Certified with CE, ISO13485, and FDA standards.

Versatile Application: Suitable for women predicting ovulation and men checking fertility.

Clear Result Interpretation: Visual pink lines indicate ovulation status clearly.

Company profile

Henan Season Medical Device Co., Ltd.

Henan, China

Business Type: Manufacturer/FactoryExport Year: 2005-08-05Nearest Port: Shanghai, TIANJINAverage Response Time: ≤5.40hTerms 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.