FDA / U.S. Compliance
- FDA Establishment Registration
- Device Listing certificates
- 510(k) summaries (if applicable)
- Letter of Authorization (LOA) for import
- ESG / FDA Importer ID (for transparency)
Compliance downloads
Download our documentation
Use this hub when hospitals, regulators, or sourcing teams request proof. Every category mirrors the library stored with Florence so you can pull FDA registration exports, ISO certificates, QA validations, pack specs, and logistics references without digging through folders.
Highlights
- FDA & SAM registration proof
- ISO, GMP, and sterilization certificates
- Lead-time bands, MOQs, and pallet specs
- Corporate, legal, and policy docs
Need a signed copy? Email compliance@florenceinternational.health.
Quality & Manufacturing
- 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 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
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 Docs
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
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