The Enbio PRO is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is…
The Enbio PRO is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The Enbio PRO has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization.
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Zhejiang (1).
Record
Regulatory record for Enbio PRO (ver. USA/CAN) | Listed by | Enbio Group AG, Switzerland |
| FDA product code | FLE |
| Device type | Sterilizer, Steam |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6880 |
| Establishment | Manufacturer, Exporter |
| Record published | 2026-03-02 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.