{
 "schemaVersion": 1,
 "generatedAt": "2026-09-06",
 "title": "Chinese medical-device establishments registered with the US FDA: retest of the 2026-08-12 census",
 "source": "openFDA device/registrationlisting bulk export (public, no authentication), partitions 0001-of-0002 and 0002-of-0002",
 "sourceExportDate": "2026-09-04",
 "sourceRecordsAllCountries": 337673,
 "frame": "Every device registration-listing record whose registration.iso_country_code is CN. No sampling inside the frame.",
 "unitOfAnalysis": "Distinct establishment, keyed on registration.registration_number (falling back to fei_number).",
 "scope": "Retest of the four headline counts only. The 2026-08-12 dataset also publishes establishment-type, export-role and US-agent breakdowns; those are not recomputed here because the bulk export carries establishment_type as [null] on many records and the original classification could not be confirmed.",
 "chinaListingRecords": 42098,
 "chinaDistinctEstablishments": 5012,
 "listingRecordsPerEstablishment": {
  "median": 4,
  "max": 651
 }
}
