Who else makes this device?

Name: Enbio Data Viewer
Brand: Enbio Data Viewer

General Hospital › MiscellaneousSterilizer, Steam

Enbio Data Viewer

Software dedicated only to the Enbio autoclaves and created by our company. It will be a read-only, visualization software for carried out sterilization or test cycles. This software will…

Registry build 21.09.26

Software dedicated only to the Enbio autoclaves and created by our company. It will be a read-only, visualization software for carried out sterilization or test cycles. This software will not be a software necessary for the proper operation of the device and may not be used by the end user at all. Also will not give the possibility of any interference in the device operating parameters and records of sterilization or tests carried out.

3manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (1), Guangdong (1), Zhejiang (1).

Chinese manufacturers registered for FDA product code FLE
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Guangzhou Ajax Medical Equipment Co Ltd	Guangzhou	Guangdong	Manufacturer	13
Ningbo Ican Machines Co., Ltd.	Ningbo	Zhejiang	Manufacturer	1

Record

Regulatory record for Enbio Data Viewer
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	2022-03-01

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Over the counter	Yes
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Enbio Data Viewer
Catalogue number	Size	Status
17		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Amsco	Steris Mexico, S. de R.L. de C.V.	434
Getinge 500 Series	Getinge IC Production Poland sp. z o.o.	133
Getinge 700 Series	Getinge IC Production Poland sp. z o.o.	82
Aesculap	Aesculap AG	67
Getinge 600 Series	Getinge IC Production Poland sp. z o.o.	61
Sterilizer, Steam	Steris Mexico, S. de R.L. de C.V.	53
Getinge 800 Series	Getinge IC Production Poland sp. z o.o.	41
Getinge 400 Series	Getinge IC Production Poland sp. z o.o.	37
Primus Sterilizer	Primus Sterilizer Company, LLC.	24
Midmark	Midmark Corporation	21
Bravo 17V Autoclave	Scican Ltd.	19
Atlas	Steris Mexico, S. de R.L. de C.V.	18

Showing 12 of 119. All products under Sterilizer, Steam

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K260254	2026-02-26
K213991	2022-02-22
K210279	2021-10-29

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.