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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

Available

Type

Accufast/OEM, Ivd Reagent

Classification

Imaging Diagnostic Equipment

Model NO.

M60D

Certification

CE, ISO13485 Ukca

Group

Female

Shelf Life

3 Years

Material

Plastic, ABS

Specimen

Urine

Package

OEM Available Upon Request

Language Version

English, French or Custom

Advantage

Integrity and Strict Quality Control

Sensitivity

10miu/Ml or 25miu/Ml

Transport Package

Plastic Bag, Sealed Carton

Specification

6.0mm

Trademark

OEM/ Neutral

Origin

China

HS Code

3002150090

Production Capacity

100000

Key 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:
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