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Wholesale Ce/ISO Certificate HCG Pregnancy Test Kit
US$0.05-0.27
1,000 Pieces
Sample price:US$0.00/piece.Request sample
Product profile
Customization
AvailableType
IVD Reagent, Ivd ReagentCertificate
CEModel NO.
Strip/Cassette/MidstreamQuality Guarantee Period
3 YearsGroup
FemaleLogo Printing
Singclean or Customized BrandUse
Home or Hospital UseTypes
Strips/Midstream/CassettePacking
Box and CartonTransport Package
Carton or Customized PackageSpecification
2.5/3/4 mm for strip, 3 & 4 mm for cassetteTrademark
Singclean or Customized brandOrigin
ChinaProduction Capacity
10000/DayKey features
High Sensitivity Detection: Detects hCG at 10, 20, or 25mIU/mL for early pregnancy identification.
Multiple Format Options: Available in Strip, Cassette, and Midstream formats to suit various needs.
OEM and Customization: Supports customized logo printing, packaging, and shell designs for brands.
Certified Quality Assurance: Holds CE 0123, ISO 9001, and ISO 13485 certificates with over 99% accuracy.
Versatile Usage Scenarios: Designed for both professional clinical settings and convenient home use.
Fast Sample Lead Time: Samples available the next day after freight receipt or within 7 days.
Long Shelf Life: Ensures product stability with a 36-month shelf life when stored correctly.
Comprehensive Quality Control: 100% finished product inspection by 66 QA/QC inspectors before shipment.
Company profile
CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Full Customization CertifiedExport Year: Shanghai Port CertifiedNearest Port: Shanghai PortAverage Response Time: ≤5.10h
AI-Powered supplier vetting
SummaryThe supplier is identified as a manufacturing factory in Hangzhou’s Qiantang District, with a business scope covering medical devices, cosmetics, masks, disinfectants, technical services, and import/export activities. It reports ISO 9001:2015 and CE certifications, 100% finished-product inspection, 58 quality assurance and control inspectors, and documented corrective-action and complaint-handling procedures. Manufacturing contracts with associated subcontractors are in place, and the supplier offers OEM, ODM, and broad customization services. However, it reports no in-stock capacity, overseas warehouse, overseas showroom, overseas agents or branches, or SDK availability. No new product was developed in the past year, and the company did not conduct regular fire drills during that period. Customer-case evidence is limited to OEM service for well-known brands and participation in one offline trade event.
Supplier typeThe supplier is explicitly identified as a factory, with associated companies in manufacturing. Its registered business scope includes first-category medical device production, second-category medical device sales, cosmetics, masks, disinfectants, technical services, and import/export activities.
CertificationsThe supplier reports an ISO 9001:2015 management-system certificate and CE certification for products. It also states that quality assurance exists and that quality-control processes are supported by documented procedures and records.
R&D capabilityThe supplier reports no available SDK and no new products during the past year, which are explicit limitations for software-enabled and recent product innovation. It does provide ODM services, but the available evidence does not establish strong ongoing innovation capability.
Production capacityThe supplier is a manufacturing factory with 100% finished-product inspection, 58 quality assurance and control inspectors, listed mixing, filling, sterilizing, and packing equipment, and a reported peak-season fulfillment time of one month. Valid manufacturing contracts with associated subcontractors are in place, although the supplier has no in-stock capacity.
Customization capabilityThe supplier explicitly offers customization from samples, customization from designs, and full customization. It also provides ODM services and reports OEM capability for well-known brands, while its own-brand product quality-control capability covers Singclean and Singjoint.
Product Q&A
Q:What formats are available for the HCG pregnancy test kit?
A:
The kit is available in three formats: Strip (dipstick), Cassette (card), and Midstream (pen/pencil plus).
Q:Can I customize the logo and packaging?
A:
Yes, we offer OEM services including customized logo printing (Singclean or your brand) and customized packing options.
Q:What is the sensitivity of the test?
A:
The test has a high sensitivity of 10, 20, or 25 mIU/mL, allowing for early detection of pregnancy.
Q:What certificates does the product hold?
A:
The product is certified with CE 0123, ISO 9001, and ISO 13485, ensuring high quality and accuracy.
Q:What is the shelf life and storage condition?
A:
The shelf life is 36 months. It should be stored at a temperature between 4-30 degrees centigrade.
Send Inquiry
*To:
Hangzhou Singclean Medical Products Co., Ltd.
Hangzhou Singclean Medical Products Co., Ltd.*Content:
Supplier replies will be sent to your registered email
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