What is the lead time for sample orders?

Samples are ready the next day after receiving freight, or within 7 days if out of stock.

What certifications does the product hold?

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

Is full customization available?

Yes, full customization options are available, including different midstream pen shells.

HCG Home Rapid Test Kits for HCG Pregnancy Test with Ce/ISO

Name: HCG Home Rapid Test Kits for HCG Pregnancy Test with Ce/ISO
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 912660825

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$0.05-0.27

1,000 Pieces

Sample price:US$0.30/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent, Ivd Reagent

Types

Strip, Cassette, Midstream

Classification

Biological Diagnostics

Certification

CE, ISO13485

Group

Female

Transport Package

Box and Carton

Specification

2.5/3/4 mm for strip, 3 & 4 mm for cassette

Trademark

Singclean

Origin

China

HS Code

3822001000

Production Capacity

1800000PCS/Year

Key features

Multiple Formats Available: Offered in Strip, Cassette, and Midstream formats for versatile usage.

High Sensitivity Detection: Sensitivity levels of 10, 20, and 25 mIU/mL for early pregnancy detection.

OEM and Custom Packaging: Customized packing options and OEM logo services are fully accepted.

Long Shelf Life: Valid for 36 months when stored between 4-30 degrees centigrade.

High Accuracy Rate: Provides over 99% accuracy for qualitative hCG detection in urine.

Fast Sample Lead Time: Ready to ship the next day or within 7 days depending on stock availability.

Global Certifications: Certified with CE, ISO 9001, and ISO 13485 standards.

Full Customization Options: Supports full customization including midstream pen shell designs.

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: ≤4.62h

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.