What certifications does the product have?

The product is CE marked, ISO13485 certified, and complies with IVDD (98/79/EC).

What is the lead time for production?

Peak season lead time is one month, while off-season is within 15 workdays.

CE Marked Nasal Saliva Self Test Kits

Name: CE Marked Nasal Saliva Self Test Kits
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 1943745865

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

Negotiable

500 Pieces

Sample price:US$5.00/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Reference

in Vitro Diagnostic Directive (98/79/Ec)

Certificate

ISO13485, CE, ISO9001

Classification

Ivdd Others

Relative Sensitivity

96%

Relative Specificity

98%

Accuracy

97%

Transport Package

500test/Carton; 600test/Carton

Specification

1 test/box; 20 test/box; 50 test/box

Trademark

Singclean

Origin

China, Hangzhou

HS Code

3002150090

Production Capacity

50000/Day

Key features

Fast Result Time: Get results in just 15 minutes for rapid diagnosis.

High Accuracy: 97% accuracy with 96% sensitivity and 98% specificity.

Multiple Sample Types: Detects IgG/IgM antibodies in whole blood, serum, or plasma.

CE Marked Certification: Compliant with IVDD (98/79/EC) and ISO13485 standards.

Full Customization: OEM and ODM services available for full customization.

Low MOQ: Minimum Order Quantity starts at just 10 pieces.

100% Inspection: Every finished product undergoes visual and function 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: ≤4.72h

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.