What certifications does the product have?

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

What is the lead time for samples and bulk orders?

Sample lead time is the next day after receiving freight or within 7 days if out of stock. Bulk lead time is within 15 workdays off-season or one month during peak season.

Is the test suitable for home use?

Yes, the one-step hCG pregnancy test is suitable for both professional and home use.

Ce Approved HCG Pregnancy Test Kit Strip Midstream Cassette

Name: Ce Approved HCG Pregnancy Test Kit Strip Midstream Cassette
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 925736085

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$0.05-0.27

1,000 Pieces

Product profile

Customization

Available

Type

IVD Reagent, Ivd Reagent

Product Type

Strip

Model NO.

Strip/Cassette/Midstream

Certificate

Accuracy

Over 99%

Material

Colloidal Gold

Quality Guarantee Period

Three Years

Group

Female

Use

Home or Hospital Use

Types

Strip/Midstream/Cassette

Logo Printing

Singclean or Customized Brand

Packing

Box and Carton

Shipment

by Air or by Sea

Read Time

Within 1-3 Mintues

Features

Precise; Rapid; Sensitive

Transport Package

OEM

Specification

2.5mm; 3mm; 3.5mm; 5.5mm; 6.0mm

Trademark

Singclean or Customized

Origin

China

HS Code

3822001000

Production Capacity

10000/Day

Key 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 and Customization: Full customization support including logo printing and packaging options.

Certified Quality: CE 0123, ISO 9001, and ISO 13485 certified for safety and quality.

Rapid and Sensitive: Read results within 1-3 minutes with sensitivity of 10-25 mIU/mL.

Versatile Usage: Suitable for both professional clinical settings and home use.

Long Shelf Life: 36 months shelf life with storage temperature between 4-30 degrees.

100% Quality Inspection: Every finished product undergoes visual and functional inspection.

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: ≤4.89h

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.