What certifications does the product have?

The product is approved with CE 0123 and ISO 13485 certificates.

What is the shelf life?

The validity period is 36 months.

Singclean Sensitive Accuracy Rapid Easy HCG Urine Pregnancy Rapid Test Kit with CE

Name: Singclean Sensitive Accuracy Rapid Easy HCG Urine Pregnancy Rapid Test Kit with CE
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 623091294

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$0.05-0.27

1,000 Pieces

Sample price:US$0.01/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Applicable Stage

Early Pregnancy

Model NO.

Original

Accuracy

0.99

Detection Time

3 Minutes

Product Type

Strip

Certificate

ISO13485, CE

Use

Home or Hospital Use

Types

Strips/Midstream/Cassette

Packing

Box

Shipment

by Air or by Sea

Group

Adult

Material

Colloidal Gold

Quality Guarantee Period

3 Years

Logo Printing

Singclean or Customized Brand

Transport Package

Carton or Customized Package

Specification

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

Trademark

Singclean or Customized brand

Origin

China

HS Code

3822001000

Production Capacity

10000/Day

Key features

High Accuracy Result: Provides over 99% accuracy for reliable pregnancy detection.

Rapid Detection: Delivers qualitative results in just 3 minutes.

High Sensitivity: Detects HCG levels as low as 10-25 mIU/ml for early detection.

Multiple Formats: Available in Strip, Cassette, and Midstream options.

CE & ISO Certified: Approved with CE 0123 and ISO 13485 certificates.

Custom Branding: Supports customized logo printing and private labeling.

Flexible Packaging: Offers customized packing sizes from 1 to 100 pcs per box.

Easy Home Use: Designed for convenient and accurate home or hospital use.

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: ≤3.77h

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.