FDA.reportPublic FDA data

Enbio

Primary DI
07629999932531
Brand
Enbio
Company
Enbio Group AG
Model
Enbio S ver. Beauty
Device description
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.
Published
2026-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210279000Enbio SEnbio Group AG2021-10-29FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07629999932531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07629999932531076299999325317629999932531

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Contacts#

Phone, Email table
PhoneEmail
+48605058629lukasz.rogowski@enbio.com
+18786701641ilona.ralston@enbio.com

Regulatory Flags#

DUNS number
480232605
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07629999825710EnbioEnbio S white2026-05-12
07629999282957Enbio-Autoclave Control Firmware362026-03-02
07629999900769Enbio PRO (ver. USA/CAN)Enbio PRO (ver. USA/CAN)2026-03-02
07629999190788EnbioEnbio S Beauty2024-03-25
07629999413511EnbioEnbio S white2022-03-01
07629999504721Enbio Data Viewer172022-03-01
07629999978836Enbio-Autoclave Control Firmware352022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05902533549597Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-10-16
00724995364168AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364175AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364182AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364199AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364205AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364212AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364229AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364236AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364243AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364250AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364267AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364274AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364281AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364298AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364304AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364311AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364328AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364335AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364342AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364359AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364366AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364373AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364380AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364397AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364557AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995368562AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
05902533549511Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-05-15
07629999825710EnbioEnbio Group AGFLE2026-05-12
06972615108058icanclaveNingbo Ican Machines Co., Ltd.FLE2026-04-26