FDA Device Establishments · JSON-LD · Markdown

TYMPA HEALTH TECHNOLOGIES LTD

FEI 3017644066 · Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active

FEI Number3017644066
Owner / OperatorTympa Health Technologies Ltd (#10077963)
AddressLandmark, 33 Cavendish Square, London London, City of, W1G 0PW, GB
Mandatory US AgentPromedic, LLC
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)ERA
Regulation § (21 CFR)874.4770
Proprietary namesTympa Otoscope System (iPhone XR); Otoscope Assembly Charging Stand (iPhone 13); Tympa Otoscope System (iPhone 13); Tympa Otoscope System Cloud; Otoscope Assembly (iPhone 13); Otoscope Assembly (iPhone XR); Tympa Mobile App (iOS); Otoscope Assembly Charging Stand (iPhone XR)

External sources

Source: openFDA. Public-domain (CC0).