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Singclean HCG Pregnancy Test Kit with CE and ISO Certification
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
ChinaHS Code
3822001000Production Capacity
100000PCS/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 different needs.
Certified Quality: Holds CE 0123, ISO 9001, and ISO 13485 certifications for reliability.
High Accuracy Rate: Provides over 99% accuracy for consistent and trustworthy results.
Custom Branding: Offers Singclean or customized brand logo printing for OEM orders.
Flexible Packaging: Accepts customized packing quantities and individual foil pouch options.
Versatile Application: Suitable for both professional clinical settings and home use.
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: ≤5.19h
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 test kit?
A:
The HCG pregnancy test is available in three formats: Strip, Cassette, and Midstream.
Q:What is the sensitivity of the test?
A:
The test has a sensitivity of 10, 20, or 25mIU/mL, aiding in early pregnancy detection.
Q:Is OEM service available?
A:
Yes, we offer OEM services including customized logo printing and flexible packaging options.
Q:What certifications does the product hold?
A:
The product is certified with CE 0123, ISO 9001, and ISO 13485 standards.
Q:What is the shelf life and storage condition?
A:
The shelf life is 36 months, and 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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