Enbio PRO (ver. USA/CAN)

GUDID 07629999900769

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.

Enbio Group AG

Steam sterilizer

• Primary Device ID: 07629999900769
• NIH Device Record Key: 00696ab2-6129-4d74-be02-3e4932334236
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enbio PRO (ver. USA/CAN)
• Version Model Number: Enbio PRO (ver. USA/CAN)
• Company DUNS: 480232605
• Company Name: Enbio Group AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +18786701641
• Email: ilona.ralston@enbio.com
• Phone: +18786701641
• Email: ilona.ralston@enbio.com
• Phone: +18786701641
• Email: ilona.ralston@enbio.com
• Phone: +18786701641
• Email: ilona.ralston@enbio.com
• Phone: +18786701641
• Email: ilona.ralston@enbio.com
• Phone: +18786701641
• Email: ilona.ralston@enbio.com
• Phone: +18786701641
• Email: ilona.ralston@enbio.com
• Phone: +18786701641
• Email: ilona.ralston@enbio.com
• Phone: +18786701641
• Email: ilona.ralston@enbio.com
• Phone: +18786701641
• Email: ilona.ralston@enbio.com
• Phone: +18786701641
• Email: ilona.ralston@enbio.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07629999900769 [Primary]

FDA Product Code

• FLE: Sterilizer, Steam

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-10
• Device Publish Date: 2026-03-02

Devices Manufactured by Enbio Group AG

• 07629999282957 - Enbio-Autoclave Control Firmware: 2026-03-10 Firmware dedicated only to the Enbio S/PRO autoclave and created by our company. This firmware does not give the possibility to
• 07629999900769 - Enbio PRO (ver. USA/CAN): 2026-03-10The 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.
• 07629999900769 - Enbio PRO (ver. USA/CAN): 2026-03-10 The Enbio PRO is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to steriliz
• 07629999190788 - Enbio: 2024-04-02 The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize me
• 07629999413511 - Enbio: 2022-03-09 The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize
• 07629999504721 - Enbio Data Viewer: 2022-03-09 Software dedicated only to the Enbio autoclaves and created by our company. It will be a read-only, visualization software for c
• 07629999978836 - Enbio-Autoclave Control Firmware: 2022-03-09 Firmware dedicated only to the Enbio S autoclave and created by our company. This firmware does not give the possibility to the