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ENBIO GROUP AG

Matched from indexed company URL: Enbio Group AG

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30167773573016777357ENBIO GROUP AG1N2026-01-01Eichengasse 3 Oensingen Solothurn CH 4702

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07629999190788Enbio - The Enbio S 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 S has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization.+18786701641ilona.ralston@enbio.com
07629999282957Enbio-Autoclave Control Firmware - Firmware dedicated only to the Enbio S/PRO autoclave and created by our company. This firmware does not give the possibility to the end user of any interference in the device operating parameters and records of carried out sterilization or tests.+18786701641ilona.ralston@enbio.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2663761564412430K260254Enbio PROFLE2026-02-26
2663761211497344K213991Enbio SFLE2022-02-22
2663761825467377K210279Enbio SFLE2021-10-29
2663761808804936

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FLE32026-02-26

PMN#

GUDID#