Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013853674

FEI Number

3013853674

Entity Name

TIMPEL S.A.

City/State/Country

Sao Paulo, BR

Establishment Address

R. Simao Alvares, 356 cj. 41 - Pinheiros, Sao Paulo 05417-020, BR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Timpel S.A. (Owner Number: 10060388)

Owner / Operator Contact Address

R. Simao Alvares, 356 cj. 41 - Pinheiros, Sao Paulo, BR-SP 05417-020, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211135

PMA Number

N/A

All Registered Proprietary Names

Enlight 2100 Enlight 2100

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QEB	Ventilatory Electrical Impedance Tomograph	Anesthesiology	Class 2	868.1505	2024-09-11
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2024-09-11
QEB	Ventilatory Electrical Impedance Tomograph	Anesthesiology	Class 2	868.1505	2022-03-16

Official Correspondent

Rafael Holzhacker

US Agent Details

Matthew Dryden Business: ProMedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

Timpel S.A.

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

View Entity Profile →

Similar Registrations

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3029845	PERCUSSIONAIRE CORP.	SANDPOINT, ID, US
3016509761	TIMPEL S.A.	Pato Branco Parana, BR
3004149774	SENTEC AG	THERWIL Basel-Landschaft, CH
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN
1219324	RESPIRONICS NOVAMETRIX, LLC	Andover, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013853674. Last updated year: 2026. Please use registration number 3013853674 when referencing this establishment in official correspondence.