Fully certified under ISO 9001, ISO 13485, CE MDR, US FDA, OEKO-TEX Standard 100, and Sedex SMETA for rapid customs entry.
Quanzhou Shenghongda Hygiene Products Co., Ltd. operates under comprehensive international medical device, quality management, and ethical compliance accreditations to guarantee seamless customs clearance across European, North American, and Asian markets. Located in Quanzhou, China, our 75,000 m² production facility is certified under ISO 9001:2015, ISO 13485:2016 for medical device quality management, and EU CE MDR (Regulation (EU) 2017/745 Class I). Our manufacturing establishment is officially registered with the US FDA under FEI 3012984570. Furthermore, all infant and feminine hygiene product lines hold OEKO-TEX Standard 100 Class I certification, verifying complete absence of harmful chemical residues including chlorine, glyphosate, phthalates, and formaldehyde. For global environmental compliance, our wood pulp supply chain maintains FSC Chain of Custody (FSC-C158421) and EUDR deforestation traceability. Our facility also passes annual third-party amfori BSCI and Sedex SMETA ethical audits, providing global buyers with uncompromised corporate governance and verifiable regulatory documentation.
| Accreditation Standard | Issuing Body / Authority | Scope & Registration ID | Surveillance & Verification | Applicable Target Markets |
|---|---|---|---|---|
| ISO 13485:2016 | TÜV SÜD Product Service | Medical Devices Quality Management System | Annual Recertification Validated | European Union, UK, Japan, Australia |
| EU CE MDR (2017/745) | European Notified Body | Class I Medical Hygiene (Incontinence / Underpads) | Technical Documentation (TD) Filed | All 27 EU Member States + EEA |
| US FDA Establishment | U.S. Food & Drug Administration | FEI: 3012984570 / Device Listing | Annual Registration Active | United States & North America |
| OEKO-TEX Standard 100 | Hohenstein Institute | Product Class I (Baby Safe, Harmful Substances Tested) | Laboratory Assay Tested | Global Supermarket Retail Chains |
| FSC Chain of Custody | Forest Stewardship Council | FSC-C158421 (Sustainable Wood Fluff Pulp) | Supply Chain Audit Certified | EUDR Compliant / Global Sustainable Brands |
| amfori BSCI / SMETA | SGS / Intertek Testing | Social Responsibility & Cleanroom Ethical Audit | Grade A Facility Rating | Fortune 500 & Global Retail Audits |
U.S. Food and Drug Administration
Foreign manufacturing establishment registration for infant diapers, adult incontinence briefs & disposable hospital underpads.
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European Commission
Class I Medical Devices and EU personal protective hygiene directives compliance across European Union member states.
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Forest Stewardship Council
FSC-C152775 Chain-of-Custody 100% certified responsible forestry fluff pulp and sustainable nonwoven raw fibers.
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Sedex Global
Supplier Ethical Data Exchange SMETA 4-Pillar audit covering labor standards, health & safety, environment, and business ethics.
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amfori BSCI
Business Social Compliance Initiative workplace code of conduct: fair remuneration, ethical hours, and zero child/forced labor.
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OEKO-TEX® International Association
Class 1 baby mucous membrane contact certification ensuring total absence of 300+ harmful chemical substances, formaldehyde, pesticides, and heavy metals.
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Intertek GSV
C-TPAT global supply chain security verification, cargo protection, container seal security, and facility physical access control.
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Intertek Testing Services
Good Manufacturing Practice compliance for wet wipes, feminine hygiene pads, and infant contact absorbent sanitary products.
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SGS Quality Assured Firm
Medical devices quality management system standard for manufacturing absorbent nursing underpads and adult incontinence care.
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SGS Quality Management
International SGS quality assured firm standard for automated hygiene manufacturing, raw material traceability, and continuous quality improvement.
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China Quality Certification Centre (CQC)
Quality management system requirements for automated high-speed disposable diaper lines, QC batch traceability, and R&D.
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Social Accountability International / SGS
Leading social certification standard for factories and organizations across the globe, ensuring fair and ethical labor conditions.
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China Quality Certification Centre (CQC)
Environmental management standard ensuring energy efficiency, waste recycling, reduced carbon footprint, and clean production.
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China Quality Certification Centre (CQC)
Occupational health and safety management system protecting plant technicians, automated line operators, and logistics workers.
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