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Ultraviolet Radiation Disinfection Chamber Device

FDA product code SCS · 1 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.6511
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-01-29 – 2026-01-29

An ultraviolet radiation disinfection chamber device is intended to disinfect patient contacting medical devices using UV radiation after the device has been cleaned. Disinfection of the medical device is achieved within an enclosed chamber through the exposure to UV radiation.

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