What certifications does the product have?

The product holds CE 0123, ISO 9001, and ISO 13485 certifications.

What is the lead time for production?

Peak season lead time is one month, while off-season lead time is within 15 workdays.

Can the test be used at home?

Yes, the One-Step hCG Pregnancy Test is suitable for both professional and home use.

Cassette Type Pregnancy Test with CE

Name: Singclean High Accuracy HCG Midstream/Strip/Cassette Type Pregnancy Test with CE
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 2007910945

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$0.05-0.27

1,000 Pieces

Sample price:US$0.35/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent, Ivd Reagent

Quality Guarantee Period

3 Years

Group

Female

Logo Printing

Singclean or Customized Brand

Use

Home or Hospital Use

Types

Pen/Midstream/Pencil Plus

Packing

Box and Carton

Shipment

by Air or by Sea

Transport Package

Carton or Customized Package

Specification

3.5 mm; 5.5 mm; 6.0 mm

Trademark

Singclean or Customized brand

Origin

China

Production Capacity

10000/Day

Key features

High Accuracy Detection: Over 99% accuracy with sensitivity of 10, 20, 25mIU/mL for early pregnancy detection.

Multiple Format Options: Available in Strip, Cassette, and Midstream (Pen/Pencil Plus) formats for diverse needs.

Certified Quality: CE 0123, ISO 9001, and ISO 13485 certified for reliable and safe medical use.

Flexible OEM/ODM: Custom logo printing and customized packing options available for brand owners.

Versatile Application: Suitable for both professional hospital use and convenient home testing.

Long Shelf Life: 36 months shelf life with stable storage requirements at 4-30 degrees centigrade.

Fast Sample Lead Time: Samples available the next day after freight receipt or within 7 days.

Comprehensive Inspection: 100% finished product inspection including visual and function checks by 66 QA staff.

Company profile

Importers and ExportersExhibition Experience

Hangzhou Singclean Medical Products Co., Ltd.

Zhejiang, China

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: ≤3.91h

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.