Chinese medical-device establishments registered with the US FDA: roles, name continuity and US agent concentration

A full-frame census of Chinese medical-device establishments in the openFDA device registration-listing bulk export dated 10 August 2026. Every record whose registration country is CN was taken, with no sampling inside the frame, and deduplicated on registration number: 41,745 listing records resolve to 4,973 establishments. Variables: declared establishment types per firm (84.3% manufacture, 38.8% manufacture for another party, 36.8% export-only role, 3.4% carrying the export role and nothing else); whether the registered establishment name differs from the owner-operator firm name after normalisation (11.3%); and the concentration of the mandatory US agent (1,466 distinct agents across 4,973 establishments, the ten largest covering 35.5%, and 75.8% of agents serving exactly one). Provincial distribution is included. Registration is a filing, not an inspection or an approval, and declared roles are self-declared. A name difference is a structural observation, not a finding of wrongdoing. Medical devices only, US-facing registrations only, single snapshot with no time series. No personal names are published. Reproducible without an API key from the same public bulk files.