What is the minimum order quantity?

The minimum order quantity is 10 pieces.

What are the payment terms?

We accept LC, T/T, D/P, PayPal, Western Union, and small-amount payments.

Do you offer ODM services?

Yes, we provide ODM services and full customization options for our products.

CE 0123, ISO 9001, 13485 Strips & Tube Rapid Pregnancy Test

Name: CE 0123, ISO 9001, 13485 Strips & Tube Rapid Pregnancy Test
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 2009835365

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$0.035-0.291

1,000 Pieces

Sample price:US$0.30/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent, Test Strips & Test Tube

Ethylene Oxide Sterilization

Without Ethylene Oxide Sterilization

Group

Adult

Customized

Width, Brand, Package

Function

Early Detection of Pregnancy

Medical Type

Self-Testing

Shelf Life

3 Years

Storage

Room Temperature

Format

Strip, Cassette and Midstream

Test Time

1-3 Minutes

Specimen

Urine

Certificates

CE 0123, ISO 9001, ISO 13485

Material

Colloidal Gold

Quality Guarantee Period

Three Years

Logo Printing

Singclean® or Customized or Neutral

Transport Package

Carton

Specification

2.5/3.0/4.0/5.5/6.0 mm

Trademark

Singclean

Origin

China

HS Code

3822001000

Production Capacity

10000/Day

Key features

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

Multiple Formats Available: Offered in Strip, Cassette, and Midstream (Pen) formats for diverse user needs.

Customizable Branding: Logo printing available with Singclean, Customized, or Neutral options.

OEM and ODM Services: Full customization support including width, brand, and package design.

Long Shelf Life: Valid for 36 months when stored at room temperature between 4-30 degrees Celsius.

Rapid Results: Provides qualitative results in just 1-3 minutes using colloidal gold technology.

Certified Quality: Certified with CE 0123, ISO 9001, and ISO 13485 standards.

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

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: ≤3.73h

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.