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CE Approved Pregnancy Rapid Test Kit Early Detection HCG Urine Test
US$0.10-0.30
10,000 Pieces
Sample price:US$1.00/piece.Request sample
Product profile
Customization
AvailableType
Accufast/OEM, Ivd ReagentClassification
Imaging Diagnostic EquipmentModel NO.
M60DCertification
CE, ISO13485 UkcaGroup
FemaleShelf Life
3 YearsMaterial
Plastic, ABSSpecimen
UrinePackage
OEM Available Upon RequestLanguage Version
English, French or CustomAdvantage
Integrity and Strict Quality ControlSensitivity
10miu/Ml or 25miu/MlTransport Package
Plastic Bag, Sealed CartonSpecification
6.0mmTrademark
OEM/ NeutralOrigin
ChinaHS Code
3002150090Production Capacity
100000Key features
CE and ISO13485 Certified: Meets international safety and quality standards for medical devices.
High Accuracy Rate: Achieves over 99.99% accuracy in detecting pregnancy hormones.
Fast Reaction Time: Provides results in just 1 minute with a 3-5 minute reading window.
Long Shelf Life: Maintains stability and effectiveness for up to 3 years.
OEM and ODM Service: Accepts full customization for branding and packaging requirements.
Multi-Format Options: Available in strip, cassette, and midstream formats for various needs.
High Sensitivity: Detects HCG levels as low as 10 mIU/ml for early pregnancy detection.
Versatile Application: Suitable for both professional medical units and home self-testing.
Company profile

Business Type: Manufacturer/Factory, Trading Company CertifiedNearest Port: Shanghai Port, Beijing PortAverage Response Time: ≤3.51h CertifiedTerms of Payment: LC, T/T, D/P, etc. CertifiedInternational Commercial Terms(Incoterms): FOB, CIF, CFR
AI-Powered supplier vetting
SummaryHebei Times Medical Technology Co., Ltd. is identified as a China-based manufacturer/factory engaged in medical devices and in vitro diagnostic reagents, including urine test strips, infectious disease tests, uncut sheets, and related raw materials. The supplier reports ISO 9001 certification, 21–30 years of combined R&D engineer experience, 50 quality-control staff, and five production lines. It states that it has 14 years of industry experience, a mature supply chain, and partners in more than 50 countries, with customer deployments across multiple regions. However, the available trade records show only one transaction per listed period and a single associated buyer in Vietnam, so the breadth of independently evidenced customer cases and trading history remains limited. Evidence is insufficient to assess financial credibility, customization capability, or after-sales service in detail.
Supplier typeThe supplier is explicitly identified as Hebei Times Medical Technology Co., Ltd., a manufacturer/factory based in Hebei, China. Its stated business focuses on the research, development, and sales of medical devices and in vitro diagnostic reagents.
CertificationsThe supplier reports holding ISO 9001 certification. This provides explicit evidence of a certified quality-management system, although no additional certifications are stated.
R&D capabilityThe company states that it conducts research and development in medical devices and in vitro diagnostic reagents, and reports 21–30 years of total R&D engineer experience. Its product scope includes diagnostic tests and home-diagnosis products, supporting an R&D presence, but no specific patents, new-product results, or documented innovation achievements are provided.
Production capacityThe supplier is classified as a manufacturer/factory and reports five production lines, 50 quality-control staff, a mature supply chain, and quality control covering semi-finished products, plastic parts, accessories, and production equipment. These stated resources support production capability, although actual capacity utilization and delivery performance are not documented.
Product Q&A
Q:What is the sensitivity of the test?
A:
The test offers high sensitivity, detecting HCG levels of 10 mIU/ml or 25 mIU/ml.
Q:How long is the shelf life?
A:
The product has a shelf life of 3 years when stored properly.
Q:Is OEM or private labeling available?
A:
Yes, we accept OEM/ODM customization and can provide private labeling services.
Q:What certifications does the product have?
A:
The test kit is certified with CE, ISO13485, UKCA, NMPA, and FSC.
Q:How fast are the results?
A:
The reaction time is 1 minute, with results readable within 3 to 5 minutes.
Send Inquiry
*To:
Hebei Times Medical Technology Co., Ltd.
Hebei Times Medical Technology Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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