Certifications & Regulatory Approvals

Complete documentation of our product safety, efficacy, and regulatory compliance for distributor due diligence

US FDA

US FDA Registration

FDA Facility Registration

Our manufacturing facility is registered with the US Food and Drug Administration, demonstrating compliance with US regulatory standards for medical devices and healthcare products.

Status: Active Registration

Company: Wenzhou Qingcheng Healthcare Tech Ltd.

Patent Portfolio

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United States Patent Application

Application Number

18/420,246

Filing Date: January 23, 2024

Type: Utility Patent

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China Invention Patent

Application Number

202310268549.8

Filing Date: March 20, 2023

Type: Invention Patent

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China Invention Patent

Application Number

202310268549.8

Filing Date: March 20, 2023

Type: Invention Patent

Safety Test Reports

Acute Oral Toxicity Test

Standard: GB 27952-2020

Test Subject: Mouse acute oral toxicity

Result: LD50 > 5000mg/kg - Practically Non-Toxic

Testing Agency: Zhongying Quality Inspection Technology Co., Ltd.

Complete Skin Irritation Test

Standard: GB 27952-2020

Test Subject: Rabbit complete skin irritation

Result: No Irritation (Grade 0)

Testing Agency: Zhongying Quality Inspection Technology Co., Ltd.

Micro-Nucleus Test

Standard: GB 27952-2020

Test Subject: Mouse bone marrow erythrocyte micro-nucleus

Result: Negative - No Mutagenic Effect

Testing Agency: Zhongying Quality Inspection Technology Co., Ltd.

Multiple Skin Irritation Test

Standard: GB 27950-2020

Test Subject: Rabbit multiple complete skin irritation

Result: No Irritation

Testing Agency: Zhongying Quality Inspection Technology Co., Ltd.

Metal Corrosion Test

Standard: GB/T 38498-2020

Test Subject: Stainless steel, carbon steel, copper, aluminum

Result: Minimal Corrosion - Safe for Metal Surfaces

Testing Agency: Zhongying Quality Inspection Technology Co., Ltd.

Vaginal Mucosa Irritation Test

Standard: Disinfection Technical Standard (2002)

Test Subject: Vaginal mucosa irritation

Result: No Irritation

Testing Agency: Zhongying Quality Inspection Technology Co., Ltd.

Efficacy Test Reports

Bactericidal Test

Test Organisms: Staphylococcus aureus, Escherichia coli, Candida albicans

Method: Suspension quantitative germicidal test

Result: ≥ 5.00 log reduction - Qualified

Testing Agency: Zhongying Quality Inspection Technology Co., Ltd.

Sporicidal Test

Test Organism: Bacillus subtilis var. niger spores (ATCC 9372)

Method: Carrier quantitative germicidal test

Result: Effective sporicidal activity

Testing Agency: Zhongying Quality Inspection Technology Co., Ltd.

Hospital Infection Bacteria Test

Test Organisms: Pseudomonas aeruginosa, common hospital infection bacteria

Method: Suspension quantitative germicidal test

Result: Effective elimination

Testing Agency: Zhongying Quality Inspection Technology Co., Ltd.

Manufacturing Certifications

Disinfection Product Manufacturing License

Holder: Zhongjia (Contract Manufacturer)

License Type: Disinfection Product Manufacturing Enterprise Hygiene License

Status: Valid

Product Filing Registration

Product: Paiweining Disinfectant Series

Filing: Registered with health authorities

Status: Filed and Approved

Product Hygiene Safety Evaluation Report

Product: Paiweining Disinfectant Series

Content: Comprehensive safety and efficacy evaluation

Status: Completed and Approved

China Product Registrations

Disinfectant Spray

Registration Number: 12-89-1

Product: Paiweining Disinfectant

Status: Registered

Hand Sanitizer

Registration Number: 12-92-1

Product: Paiweining Hand Sanitizer

Status: Registered

Oral Antibacterial Gel

Registration: XD05242-2023

Product: Yavining Oral Antibacterial Gel

Status: Registered

Request Full Documentation Package

For distributors and partners, we provide complete test reports, certificates, patent documents, and regulatory filing packages. Contact us to receive the full documentation package for your market.

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