What certifications does the product have?

The product is CE 0123, ISO 9001, and ISO 13485 certified.

What is the shelf life and storage condition?

The shelf life is 36 months, and it should be stored at 4-30 degrees centigrade.

Can it be used at home?

Yes, the test is suitable for both professional and home use.

Singclean Rapid One Step Lab Urine Pregnant Test for Home

Name: Singclean Rapid One Step Lab Urine Pregnant Test for Home
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 2046625685

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$0.05-0.27

1,000 Pieces

Sample price:US$20.00/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

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

Accuracy

Over 99%

Read Time

Within 1-3 Mintues

Features

Precise; Rapid; Sensitive

Transport Package

Carton or 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 Sensitivity: Detects hCG at 10, 20, or 25mIU/mL for early pregnancy detection.

Over 99% Accuracy: Provides reliable qualitative results for hCG in human urine.

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

OEM Customization: Custom logo printing and OEM packing options are accepted.

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

Rapid Results: Read results within 1-3 minutes using colloidal gold method.

Versatile Use: Suitable for both professional medical and home use.

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

Company profile

Hangzhou Singclean Medical Products Co., Ltd.

Zhejiang, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service AvailableExport Year: 2022-12-20 CertifiedNearest Port: Ningbo Port, Shanghai PortAverage Response Time: ≤3.10h CertifiedTerms of Payment: LC, T/T, D/P, etc.

AI-Powered supplier vetting

SummaryThe supplier is a China-based medical-products factory headquartered in Hangzhou, Zhejiang, with 420 employees and operations established in the early 2000s. It reports seven production lines, a 17,000 m² manufacturing plant, ISO 9001:2015 and ISO 14001:2015 certification, OEM/ODM services, and stated antigen rapid test-kit capacity of 10 million pieces annually. Its products and services cover in-vitro diagnostics, absorbable hemostatic products, hyaluronic-acid-related medical products, and other medical devices. The supplier reports export coverage across multiple global regions, more than 120 export destinations in a company description, and delivery within 15 working days off-peak or one month during peak periods. Evidence supports strengths in factory operations, quality systems, production scale, customization, and R&D. After-sales capability, financial credibility, and specific customer cases are not sufficiently documented in the provided slices.

Supplier typeThe supplier is identified as a manufacturing factory in Hangzhou, China, with a limited-company structure and medical-device products as its main offering. This supports classification as a direct medical-products manufacturer rather than only a trading intermediary.

CertificationsThe supplier reports ISO 9001:2015 and ISO 14001:2015 certifications, along with other unspecified certifications. These explicitly indicate documented quality-management and environmental-management systems, although the unspecified certifications cannot be assessed further.

R&D capabilityThe supplier reports dedicated R&D engineers, more than 20 years of absorbable-biomaterials expertise, a strong R&D team, and ongoing development of medical and tissue-engineering products. The slices explicitly support substantial innovation activity and industry experience.

Production capacityThe supplier reports a 17,000 m² plant, seven production lines, daily capacity of 500,000 pieces in a company description, annual antigen rapid test-kit output of 10 million pieces, and stated delivery times of within 15 working days off-peak and one month during peak season. These figures provide explicit evidence of meaningful production scale and fulfillment capability.

Customization capabilityThe supplier explicitly offers OEM and ODM services according to client needs. This is direct evidence that it can support customized product development or manufacturing arrangements.