FDA Establishment Registration
Importer (U.S.) and manufacturer (Mexico) registration numbers with prefilled RL links.
Verify Registration →Compliance Library
This library keeps every document buyers and regulators ask for straight from the source. We use FDA accurate language (registered/listed for establishments and devices; 510(k) cleared only where applicable) and never label PPE as FDA approved. Verify everything here and mirror the file names across WordPress, quotes, and shared folders.
U.S. Regulatory Status
Current registration and listing status for U.S. Import and Manufacturing entities.
FDA Device Listings
List by product family with product codes (FXX, FYA, etc.) and listing IDs.
View Listings →510(k) Summaries
Upload only if you have clearance; include K number or note "Not applicable" for Class I exempt.
Download 510(k) →Importer of Record
PDF outlining importer role, U.S. Agent, EIN, and compliance contacts.
Download Statement →Quality Systems & Certifications
ISO 13485:2016
Covers Intercambio Global Latinoaméricascope and expiry.
View CertificateSterilization Validation
Method (EO or Gamma), SAL 10^-6, lab, and issuance date.
View ValidationInternal QA Summary
Audit cadence, key controls, and responsible team structure.
Download OverviewGMP Compliance
Declaration of conformity to U.S. Good Manufacturing Practices.
View LetterStandards & Test Reports
Pair every performance claim with a current lab report.
Surgical & Isolation Gowns
Surgical Masks
Procedure Packs
Doc naming format:
<Standard>_<Product>_<Entity>_<YYYY-MM>_vX.Y.pdf
Labeling & Instructions for Use (IFU)
UDI & GTIN Samples
Carton, inner pack, and sterile pack labels with GTIN, lot, expiry, and AAMI/ASTM level.
View Label PackInstructions for Use
Bilingual IFUs for gowns, masks, drapes, and accessory kits.
View IFUsUDI Data Table
SKU, device identifier, production identifier, performance level, and label version.
Download Data SheetDocumentation Hub
Central access for all technical files. Share this link as the single source of truth.
Open Full HubFDA / U.S. Compliance
- FDA Establishment Registration
- Device Listing certificates
- 510(k) summaries
Quality & Manufacturing
- ISO 13485 certificate
- Sterilization validation
- Biocompatibility testing
Product Specs
- Spec Sheets & Dimensions
- Pack Configurations
- Material Safety (MSDS)
Logistics
- Packaging & Palletization
- Lead Times & MOQs
- Customs Compliance
Operational / Internal Reference
Logistics, Packaging & Supply Chain
Packaging Specs
- Case pack, dimensions, and weight
- Pallet pattern, height, and weight
- HTS code, country of origin
Lead Times & MOQs
- Standard lead-time bands
- Surge capacity details
- Replenishment pathways
Logistics Flow
- Mfg → QA → CEDIS → Border → U.S. 3PL
- Certificates of Conformance
Corporate & Legal Documentation
Corporate Overview
- EIN, CAGE code, DUNS number
- Business registration documents
Insurance
- General / Product liability
- Workers comp
Policies
- Code of Conduct
- Anti-bribery / Supply Chain
- Privacy & Terms
Cross Reference (Mexico to U.S.)
Mapping Mexican Clave Sector Salud codes to Florence SKUs.
| Clave | Florence SKU | GTIN | Description | Sterility | Level |
|---|---|---|---|---|---|
| [Clave] | [SKU] | [GTIN] | [Description] | [Sterile/Non] | [Level] |
How to Verify Our Regulatory Status
1
Check FDA Registration
Use prefilled FDA RL links for both entities. Confirm status is "Active".
Open FDA Database (Importer) Open FDA Database (Mfg)
2
Confirm Device Listings
Match Product Code (e.g. FYA) and Device Class to the RL detail page.
3
Match Test Reports
Ensure the test date precedes the first sale and names the correct model.
4
Verify Update Cadence
Library reviewed quarterly. FDA data refreshes weekly.
Internal Document Control Checklist
- Log every document source, owner, and review date.
- Ensure product claims reference a library doc.
- Replace PDFs immediately on renewal.