Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680101

FEI Number

3002806590

Entity Name

BAUMER S.A.

City/State/Country

MOGI MIRIM - SP Sao Paulo, BR

Establishment Address

AV. PREF. ANTONIO TAVARES LEITE, 181, PARQUE DA EMPRESA, MOGI MIRIM - SP Sao Paulo 13803-330, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BAUMER S.A. (Owner Number: 9006781)

Owner / Operator Contact Address

Av. Prefeito Antonio Tavares Leite, 181, Distrito Industrial I Jose Marangoni, Mogi Mirim, BR-SP 13803-330, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Washer Desinfector TW-E2000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEC	Disinfector, Medical Devices	General Hospital	Class 2	880.6992	2024-10-31

Official Correspondent

No official correspondent registered.

US Agent Details

PASSARINI CRO AND REGULATORY SOLUTIONS LLC Email: usagent@passarini.com.br Phone: (786) 8496760

Related Public Records

Same Entity

BAUMER S.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2026	Getinge Disinfection Ab Ljungadalsgatan	2	Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Z-0018-2014	Getinge Disinfection Ljungadalsgatan	2	Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680101. Last updated year: 2026. Please use registration number 9680101 when referencing this establishment in official correspondence.