{
 "schemaVersion": 1,
 "generatedAt": "2026-08-12",
 "title": "Chinese medical-device establishments registered with the US FDA: roles, name continuity and US agent concentration",
 "source": "openFDA device/registrationlisting bulk export (public, no authentication), partitions 0001-of-0002 and 0002-of-0002",
 "sourceExportDate": "2026-08-10",
 "sourceRecordsAllCountries": 333181,
 "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). Both keys yield the same count.",
 "chinaListingRecords": 41745,
 "chinaDistinctEstablishments": 4973,
 "listingRecordsPerEstablishment": {
  "median": 4,
  "max": 648,
  "note": "This is why record counts must not be read as firm counts: 41,745 listing records resolve to 4,973 establishments."
 },
 "establishmentTypes": {
  "note": "Multi-valued: one establishment may register several roles, so shares sum above 100%.",
  "counts": [
   {
    "type": "Manufacture Medical Device",
    "establishments": 4193,
    "share": 84.3
   },
   {
    "type": "Manufacture Medical Device for Another Party (Contract Manufacturer)",
    "establishments": 1928,
    "share": 38.8
   },
   {
    "type": "Export Device to the United States But Perform No Other Operation on Device",
    "establishments": 1828,
    "share": 36.8
   },
   {
    "type": "Repack or Relabel Medical Device",
    "establishments": 317,
    "share": 6.4
   },
   {
    "type": "Develop Specifications But Do Not Manufacture At This Facility",
    "establishments": 189,
    "share": 3.8
   },
   {
    "type": "Sterilize Medical Device for Another Party (Contract Sterilizer)",
    "establishments": 145,
    "share": 2.9
   },
   {
    "type": "Foreign Private Label Distributor",
    "establishments": 136,
    "share": 2.7
   },
   {
    "type": "Complaint File Establishment per 21 CFR 820.198",
    "establishments": 87,
    "share": 1.7
   },
   {
    "type": "Remanufacture Medical Device",
    "establishments": 65,
    "share": 1.3
   },
   {
    "type": "Reprocess Single-Use Device",
    "establishments": 24,
    "share": 0.5
   }
  ]
 },
 "exportOnly": {
  "establishments": 170,
  "share": 3.4,
  "definition": "Registered for the export role and no other role."
 },
 "nameContinuity": {
  "compared": 4973,
  "different": 561,
  "share": 11.3,
  "method": "Case-folded, punctuation-stripped, common corporate suffixes removed (co/corp/company/inc/ltd/limited/llc/gmbh/technology/tech), whitespace collapsed. A difference after that is a genuinely different name string, not a formatting variant.",
  "caution": "A different name is not evidence of anything improper. Group structures (a China subsidiary owned by a foreign parent) account for many of them."
 },
 "usAgents": {
  "establishmentsWithAgent": 4973,
  "distinctAgents": 1466,
  "agentsServingExactlyOne": 1111,
  "top10Share": 35.5,
  "top": [
   {
    "agent": "regrek llc",
    "establishments": 732,
    "share": 14.7
   },
   {
    "agent": "registrar corp",
    "establishments": 331,
    "share": 6.7
   },
   {
    "agent": "irc usa",
    "establishments": 134,
    "share": 2.7
   },
   {
    "agent": "fanfei liu",
    "establishments": 108,
    "share": 2.2
   },
   {
    "agent": "abmed medical technology inc",
    "establishments": 104,
    "share": 2.1
   },
   {
    "agent": "j & f technology service",
    "establishments": 78,
    "share": 1.6
   },
   {
    "agent": "humiss inc.",
    "establishments": 75,
    "share": 1.5
   },
   {
    "agent": "kai li",
    "establishments": 73,
    "share": 1.5
   },
   {
    "agent": "mid-link international co., ltd",
    "establishments": 67,
    "share": 1.3
   },
   {
    "agent": "south bay innovation llc",
    "establishments": 61,
    "share": 1.2
   },
   {
    "agent": "medright tech inc",
    "establishments": 57,
    "share": 1.1
   },
   {
    "agent": "james h. liao",
    "establishments": 54,
    "share": 1.1
   },
   {
    "agent": "jiamei consulting  inc.",
    "establishments": 49,
    "share": 1.0
   },
   {
    "agent": "manton business and technology services",
    "establishments": 44,
    "share": 0.9
   },
   {
    "agent": "share info inc.",
    "establishments": 43,
    "share": 0.9
   }
  ],
  "note": "A US agent is mandatory for a foreign establishment, so coverage is 100% by construction. The finding is the concentration, not the presence."
 },
 "provinces": [
  {
   "province": "Guangdong",
   "establishments": 1358,
   "share": 27.3
  },
  {
   "province": "Zhejiang",
   "establishments": 904,
   "share": 18.2
  },
  {
   "province": "Jiangsu",
   "establishments": 690,
   "share": 13.9
  },
  {
   "province": "Fujian",
   "establishments": 230,
   "share": 4.6
  },
  {
   "province": "Shandong",
   "establishments": 169,
   "share": 3.4
  },
  {
   "province": "Hubei",
   "establishments": 113,
   "share": 2.3
  },
  {
   "province": "Anhui",
   "establishments": 109,
   "share": 2.2
  },
  {
   "province": "Hebei",
   "establishments": 101,
   "share": 2.0
  },
  {
   "province": "Jiangxi",
   "establishments": 57,
   "share": 1.1
  },
  {
   "province": "Henan",
   "establishments": 48,
   "share": 1.0
  }
 ],
 "limitations": [
  "Medical devices only. Nothing here generalises to other product categories.",
  "US-facing registrations only. A Chinese factory with no US device business does not appear.",
  "Registration is a filing, not an inspection or an approval. It does not mean FDA has assessed the facility or cleared its products.",
  "Establishment type is self-declared at registration.",
  "A name difference between establishment and owner-operator is a structural observation, not a finding of wrongdoing.",
  "Single snapshot of the 2026-08-10 export. No time series."
 ],
 "reproduce": "Download the two openFDA bulk partitions for device/registrationlisting, filter registration.iso_country_code == 'CN', deduplicate on registration_number, and recompute. No API key required."
}