Kamil Holub
Deymed Diagnostic s.r.o.
Kudrnacova 533
Hronov
54931 Nachod CZ
Czechia
info@deymed.comFEI 3012168464Issued Nov 7, 2023OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012168464.
OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality
Product Type
Medical Devices
Status
Closed
Closeout Letter
August 12, 2025
Summary
Deymed Diagnostic s.r.o., a Czech manufacturer of Class II medical devices including BrainFeedback Pro, TruScan LT, and DuoMAG NL, was cited for failing to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. During a July 2023 inspection, the FDA identified that the company's manufacturing methods, facilities, and controls were inadequate, with specific violations including failure to establish and maintain proper design control procedures as required by 21 CFR 820.30(a). The company's devices were determined to be adulterated due to these Quality System regulation deficiencies.
Deymed Diagnostic s.r.o. FDA Warning Letter, November 7, 2023
Talk to a Specialist