Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016509761

FEI Number

3016509761

Entity Name

TIMPEL S.A.

City/State/Country

Pato Branco Parana, BR

Establishment Address

Rua Jose Leonardi 280 Bloco A, Pato Branco Parana 85503, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TIMPEL S.A. (Owner Number: 10062190)

Owner / Operator Contact Address

Rua Jose Leonardi 280 Bloco A, Pato Branco, BR-PR 85503, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211135

PMA Number

N/A

All Registered Proprietary Names

Enlight 2100 (TPL-E2103-0) Enlight 2100

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2026-01-06
QEB	Ventilatory Electrical Impedance Tomograph	Anesthesiology	Class 2	868.1505	2026-01-06
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 →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016509761. Last updated year: 2026. Please use registration number 3016509761 when referencing this establishment in official correspondence.