Documentation Hub
Central access for all technical files. Share this link as the single source of truth for FDA registration proof, packaging specs, and certificates.
FDA / U.S. Compliance Registration, listings, and import authorization
- FDA Establishment Registration
- Device Listing certificates
- 510(k) summaries (if applicable)
- Letter of Authorization (LOA) for import
- ESG / FDA Importer ID (for transparency)
Quality & Manufacturing ISO 13485, sterilization, and testing reports
- ISO 13485 certificate
- ISO 9001 certificate (if applicable)
- GMP compliance letter
- Sterilization validation reports (EtO / Steam)
- Biocompatibility testing
- Viral penetration testing (ASTM F1671)
- Synthetic blood penetration testing
- Flammability testing
- Cytotoxicity / irritation testing
- Shelf-life validation summary
- Environmental monitoring summary
Standards & Performance AAMI and ASTM performance charts
- AAMI PB70 level certifications for gowns
- ASTM F2100 mask performance charts
- Filtration and breathability reports
- Material safety data sheets (MSDS)
- Latex-free declarations
- Country-of-origin certification
Product Documentation Specs, IFUs, and safety data
Product Specification Sheets
- Dimensions, materials, compliance standards
- Sterility status, color, weight, thickness
- Reference photo
Pack Configuration Sheets
- Standard pack layouts
- Premium pack layouts
- Custom pack capabilities
Instructions for Use (IFU)
- Sterile product IFUs
- Patient-contact material IFUs
UDI / GTIN Information
- Labeling examples and barcode formatting
- GMDN codes (optional)
Safety & Handling
- Storage requirements and disposal instructions
- Latex/chemical avoidance notes
Logistics, Packaging & Supply Chain Pallet specs, lead times, and customs
Packaging & Palletization Specs
- Case pack, dimensions, and weight
- Pallet pattern, height, and weight
- HTS code, country of origin, labeling format
Lead Times & MOQs
- Standard lead-time bands
- Surge capacity details
- Production scheduling window and MOQ per SKU
- Emergency replenishment pathways
Logistics Flow Diagram
- Manufacturing → QA → CEDIS → Border crossing → U.S. 3PL → Customer
Certificates of Conformance
- Sample CoC for hospital reference
Border / Customs Compliance
- USMCA eligibility statement
- Certificate of Origin
- Importer/Exporter ID numbers
Corporate & Legal Business entity, insurance, and policies
Corporate Overview
- EIN, CAGE code, DUNS number
- Business registration documents (optional)
Insurance Certificates
- General liability
- Product liability
- Workers comp
Ethical & Compliance Policies
- Code of Conduct
- Anti-bribery and corruption statement
- Supply chain transparency policy
- Environmental impact statement
Terms & Conditions
- Sales terms and warranty
- Returns/claims policy
Privacy & Cookie Policies
- Privacy policy
- Cookie policy
Need signed or notarized copies?
We provide authenticated documents for government tenders and legal review. Please request specific certifications via our compliance desk.