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Complaints Database

Documented violations of medical device regulations filed with authorities

1
Total Complaints
1
MDR Violations
0
FDA Violations
1
Class III Devices

Featured Cases

EU MDR Class 3

AI Dermatologist: Skin Scanner 17+

Acina

Diagnostic app claiming to detect melanoma and other skin conditions operating without proper MDR certification, missing essential documentation, and displaying fraudulent CE marking

Key Violations:

  • Lack of Instructions for Use (IFU)
  • Missing product label
  • Absence of UDI registration
  • +4 more...
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