Certifications & Regulatory Compliance Dossiers
Review Jinjiang Rong An's regulatory qualifications: ISO 9001:2015, CE MDR 2017/745 Class I compliance, and US FDA establishment registration.
ISO 9001:2015 Quality Management System
Issuing Authority: SGS / Authorized Certification Body
Design, manufacture and export of disposable adult incontinence products and hygienic articles
Reg. No: CN-ISO9001-2015-RONGANCE MDR (EU) 2017/745 Class I Medical Device
Issuing Authority: European Union CE Compliance
Disposable adult diapers, pull-up pants, and medical nursing underpads
Reg. No: CE-MDR-CN-2023-RONGANUS FDA Establishment Registration & Device Listing
Issuing Authority: U.S. Food and Drug Administration
Incontinence adult briefs and disposable underpads
Reg. No: FDA-FEI-3018892401ISO 11948-1 Rothwell Method High Absorbency Verification
Issuing Authority: Independent Third-Party Testing Laboratory
Total tested fluid retention capacity exceeds 1,200ml to 1,800ml for heavy night protection
Reg. No: ISO 11948-1-COARewet & Skin Microclimate Compliance Test
Issuing Authority: National Hygiene Testing Center
Rewet index under 0.25g at 0.5 psi pressure; zero skin irritation formulation
Reg. No: GB/T 28004.2-2021Microbiological Safety & Bioburden Compliance
Issuing Authority: National Health Quality Inspection
Total bacterial count ≤20 CFU/g, zero pathogenic bacteria, zero fluorescent agents
Reg. No: GB 15979-2002Need Full Quality Audit Dossiers or COA Copies?
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