FDA product code SBE

Digital Physical/Chemical Sterilization Process Sensor

General Hospital·Class 2·21 CFR 880.2801
US regulatory classifications
US Product Code (FDA)
SBE
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.2801
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A digital physical/chemical sterilization process sensor is a device intended to monitor one or more parameter(s) of the sterilization process. The adequacy of the sterilization conditions as measured by the parameter(s) is/are indicated by a digital readout of the result.

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About this record

Digital Physical/Chemical Sterilization Process Sensor is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.