Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007549157

FEI Number

3007549157

Entity Name

TECHNOCOM SYSTEMS SDN BHD

City/State/Country

JOHOR BAHRU, MY

Establishment Address

PLO 1 JALAN FIRMA 1, KAWASAN PERINDUSTRIAN TEBRAU 1, JOHOR BAHRU 81100, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Technocom Systems Sdn Bhd (Owner Number: 10058421)

Owner / Operator Contact Address

PLO 1 JALAN FIRMA 1, KAWASAN PERINDUSTRIAN TEBRAU 1, JOHOR BAHRU, MY-01 81100, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EVair iFlow sensor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2019-02-11
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2019-02-25

Official Correspondent

SHAW CHUAN SIM

US Agent Details

Kay Tat Ng Business: VM Services, Inc. Email: kaytat.ng@venturemfg-usa.com Phone: (949) 6897339

Related Public Records

Same Entity

Technocom Systems Sdn Bhd

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
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

Similar Registrations

Registration Number	Establishment Name	Location
3003803075	EMG TECHNOLOGY CO., LTD.	Taichung City, TW
3008496560	NINGBO GREETMED MEDICAL INSTRUMENTS CO., LTD.	Ningbo Zhejiang, CN
3007238566	BEIJING AEONMED CO., LTD.	Sanhe Hebei, CN
3012336822	GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.	Foshan Guangdong, CN
2515872	DeVilbiss Healthcare LLC.	SOMERSET, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007549157. Last updated year: 2026. Please use registration number 3007549157 when referencing this establishment in official correspondence.