Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009302812

FEI Number

3009302812

Entity Name

Tecme SA

City/State/Country

Cordoba, AR

Establishment Address

Av. Circunvalacion (N-O) Agustin Tosco 3040, Cordoba X5008HJY, AR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tecme S.A. (Owner Number: 10034919)

Owner / Operator Contact Address

Av. Circunvalacion (N-O) Agustin Tosco 3040, Cordoba, AR-X X5008HJY, AR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111595

PMA Number

N/A

All Registered Proprietary Names

TECME 33XXRXV Ventilator Model Neumovent GraphNet GraphNet Neo GraphNet Advance GraphNet TS Neumovent GraphNet Ts Neumovent GraphNet Neo Neumovent Schiller GraphNet Neo Neumovent GraphNet Advance Neumovent Schiller GraphNet Ts Neumovent Schiller GraphNet Advance

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2017-10-27
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2011-01-16
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2012-05-06

Official Correspondent

Ernesto Mana Escuti

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Tecme S.A.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120
Z-0037-04	VIASYS Med Systems	1	Sideport Kit, consisting of an adjustable sideport valve and an O2 port elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83166

Similar Registrations

Registration Number	Establishment Name	Location
9680661	Mallinckrodt Dar S.r.l.	MIRANDOLA Modena, IT
2523320	Keystone Industries	Myerstown, PA, US
9616445	VADI Medical Technology Co., Ltd.	Taoyuan City, TW
3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
3038562397	Respironics Medical Products (Shenzhen) Co., Ltd.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009302812. Last updated year: 2026. Please use registration number 3009302812 when referencing this establishment in official correspondence.