CHENRUI MYPAL®

International Accreditation & Audit Dossiers

Chenrui (Fujian) Industry and Trade Co., Ltd. maintains a comprehensive international accreditation framework and technical regulatory dossier supporting rapid customs clearance in over 88 destination countries. Operating from our 230,000 m² smart manufacturing campus in Quanzhou, China, with 75,000 m² of ISO Class 100,000 GMP dust-free cleanrooms, all hygiene production adheres to ISO 9001:2015, ISO 13485:2016 for medical devices, ISO 14001:2015, and ISO 45001:2018. For United States distribution, our adult incontinence briefs and nursing underpads are registered under active US FDA 21 CFR Class I medical device facility establishment listings. In the European Union, products fully comply with Medical Device Regulation CE MDR (EU) 2017/745 and REACH chemical safety directives. Contact raw materials carry OEKO-TEX Standard 100 Class 1 infant certifications and FSC Chain-of-Custody verification, while factory social ethics are independently audited through Sedex SMETA 4-Pillar and amfori BSCI standards.

FDA Registration

FDA Registration

U.S. Food and Drug Administration

Foreign manufacturing establishment registration for infant diapers, adult incontinence briefs & disposable hospital underpads.

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CE Marking

CE Marking

European Commission

Class I Medical Devices and EU personal protective hygiene directives compliance across European Union member states.

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FSC® Certification

FSC® Certification

Forest Stewardship Council

FSC-C152775 Chain-of-Custody 100% certified responsible forestry fluff pulp and sustainable nonwoven raw fibers.

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Sedex Member

Sedex Member

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

amfori BSCI

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 Standard 100

OEKO-TEX Standard 100

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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GSV Security

GSV Security

Intertek GSV

C-TPAT global supply chain security verification, cargo protection, container seal security, and facility physical access control.

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GMPC Intertek

GMPC Intertek

Intertek Testing Services

Good Manufacturing Practice compliance for wet wipes, feminine hygiene pads, and infant contact absorbent sanitary products.

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ISO 13485:2016

ISO 13485:2016

SGS Quality Assured Firm

Medical devices quality management system standard for manufacturing absorbent nursing underpads and adult incontinence care.

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ISO 9001:2015

ISO 9001:2015

SGS Quality Management

International SGS quality assured firm standard for automated hygiene manufacturing, raw material traceability, and continuous quality improvement.

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ISO 9001:2015

ISO 9001:2015

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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SA 8000

SA 8000

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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ISO 14001:2015

ISO 14001:2015

China Quality Certification Centre (CQC)

Environmental management standard ensuring energy efficiency, waste recycling, reduced carbon footprint, and clean production.

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ISO 45001:2018

ISO 45001:2018

China Quality Certification Centre (CQC)

Occupational health and safety management system protecting plant technicians, automated line operators, and logistics workers.

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International Certification Dossiers & Regulatory Specifications

Full Legal Dossier Available for Importer Clearance
Certification & Standard Accreditation Body Product & Facility Scope Engineering Benchmark & Limits Target Export Jurisdiction
ISO 13485:2016 CQM / IQNET Medical Incontinence & Cleanroom Hygiene 75,000 m² Class 100,000 GMP Cleanrooms Global Hospital & Pharmacy Channels
US FDA 21 CFR 876/880 U.S. Food & Drug Administration Foreign Facility Registration & Device Listing Class I Medical Incontinence & Bed Pads United States & North America Customs
EU CE MDR 2017/745 European Commission Competent Authority Adult Incontinence Briefs & Nursing Pads Rewet < 0.12 g under 5.0 kPa load pressure European Union (27 Member States)
OEKO-TEX Standard 100 TESTEX Swiss Textile-Testing Institute Class 1 (Infant Skin Contact Materials) Zero formaldehyde, < 0.1 ppm pesticide residues Worldwide Infant Care Brands
FSC® CoC Forest Stewardship RINA Services S.p.A. Chain-of-Custody Fluff Pulp & Tissue Matrix 100% Sustainable Plantation Pulp (EUDR compliant) European Union & North America
Sedex SMETA & amfori BSCI SGS / Intertek Third-Party Auditors 4-Pillar Social & Workplace Ethics Audit A-Grade Workplace Standards, 0 Non-Conformances Global Supermarket Retail Chains
Verified OEM Engineering Dossier, ISO 11948-1 Test Benchmarks & 20GP/40HQ Container Spec (International Certifications Regulatory Compliance Dossiers) RW-HYGIENE-M2 Verified ▾

Chenrui (Fujian) Industry and Trade Co., Ltd. (MYPAL®) manufactures and exports International Certifications Regulatory Compliance Dossiers from our 50000 m² Quanzhou facility operating 18 full-servo lines at 800 pcs/min with an annual output exceeding 2.1 billion pcs (Fact ID: RW-HYGIENE-0002). Each production batch utilizes a 0.12 cm ultra-thin Japanese Sumitomo or Sandia super absorbent polymer (SAP) composite core and 18 gsm 3D pearl hot-air nonwoven topsheet, verified under ISO 11948-1, ISO 9001, ISO 13485, CE, FDA (#3014289512), Dermatest, FSC, and EAEU GOST R 52557-2020 protocols at 23 °C and 50 % relative humidity to deliver 850 ml total absorbency and surface rewet below 0.5 g. Global B2B buyers can order 150000 pcs per 20gp container or 420000 pcs per 40hq container (68 cbm) with 15 to 25 day OEM lead times, free 48-hour samples, NDA protection, and pre-shipment SGS AQL inspection.

Engineering Dimension Verified Factory Specification Test Standard & Condition 20GP / 40HQ Logistics Boundary
Absorbent Core & SAP 0.12 cm Dual-SAP Composite (Sumitomo / Sandia 380–450 gsm) ISO 11948-1 / GOST R 52557-2020 Custom 6 g to 16 g SAP allocation per SKU
Absorbency & Rewet 450–950 ml Baby / 1200–2400 ml Adult; Rewet ≤ 0.5 g 23 °C, 50 % RH, 0.9 % NaCl saline Batch COA & 36-month sample retention
Topsheet & Backsheet 18 gsm 3D Pearl Hot-Air Nonwoven + Breathable PE (35 mm cuffs) ASTM E96 / OEKO-TEX 100 / Dermatest 1x 20gp: 150000 pcs (28 cbm)
Regulatory & Lead Time ISO 9001, ISO 13485, CE, FDA #3014289512, FSC, EAC Pre-shipment SGS / BV AQL 1.5/2.5 1x 40hq: 420000 pcs (68 cbm, 15–25 days)
3-Tier B2B Risk Reversal: Tier 1 Free 48h Sample Kit (Freight Credit) · Tier 2 Golden Sample Sign-Off · Tier 3 SGS/BV Pre-Shipment AQL Inspection
Request Sample & BOM Quote → Full Specification Catalog sales@chinadiaperfactory.com

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