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Ce/ISO Certificated HCG Pregnancy Urine Test Kit Strip Midstream Cassette
US$0.05-0.27
1,000 Pieces
Product profile
Customization
AvailableType
IVD Reagent, Ivd ReagentProduct Type
StripModel NO.
Strip/Cassette/MidstreamCertificate
CEAccuracy
Over 99%Material
Colloidal GoldQuality Guarantee Period
Three YearsGroup
FemaleUse
Home or Hospital UseTypes
Strip/Midstream/CassetteLogo Printing
Singclean or Customized BrandPacking
Box and CartonShipment
by Air or by SeaRead Time
Within 1-3 MintuesFeatures
Precise; Rapid; SensitiveTransport Package
OEMSpecification
2.5mm; 3mm; 3.5mm; 5.5mm; 6.0mmTrademark
Singclean or CustomizedOrigin
ChinaHS Code
3822001000Production Capacity
10000/DayKey features
High Accuracy Rate: Over 99% accuracy for reliable early pregnancy detection results.
Multiple Formats Available: Choose from Strip, Midstream, or Cassette formats to suit your needs.
OEM Branding Service: Customized logo printing with Singclean or your own brand accepted.
CE & ISO Certified: Certified with CE 0123, ISO 9001, and ISO 13485 standards.
Rapid Sensitivity: Detects hCG at 10, 20, or 25mIU/mL for early detection.
Long Shelf Life: 36 months shelf life with storage between 4-30 degrees centigrade.
Versatile Application: Suitable for both professional clinical and home use scenarios.
Flexible Packaging: Customized packing options available for strips, cassettes, and midstreams.
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: ≤4.02h
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 are the available formats for this test kit?
A:
The HCG Pregnancy Test is available in three formats: Strip (dipstick), Cassette (card), and Midstream (pen/pencil plus).
Q:Is OEM branding available for this product?
A:
Yes, OEM logo printing is accepted. You can choose Singclean or a customized brand for your packaging.
Q:What is the accuracy of the test?
A:
The test kit offers an accuracy rate of over 99% for qualitative determination of hCG in urine specimens.
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 requirement?
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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