Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710116

FEI Number

3003348851

Entity Name

DISPO-MED (MALAYSIA) SDN BHD

City/State/Country

Shah Alam Selangor, MY

Establishment Address

No. 3, Jalan Meteor U16/153A, Elmina, Sekysen 16, Shah Alam Selangor 40160, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dispo-Med (MALAYSIA) SDN BHD (Owner Number: 10048710)

Owner / Operator Contact Address

No. 3, Jalan Meteor U16/153A, Elmina, Sekysen 16, Shah Alam, MY-10 40160, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dispo-Med Face Shield O2 Cannula DM-6500 DUO Flow O2 and CO2 Sampling Cannula DM-4441 LO-FLO CO2 Sampling Cannual with Dual O2 Delivery DM-1000 Nasal CO2 Sampling Line Gas Sampling Cannula DM-4100 CO2 Sampling Cannula with Filter DM-7700 Gas Sampling Line with T-Connector & Filter CO2 Sampling Cannula w/ O2 Delivery Line Gas Sampling Line DM-7100 Gas Sampling Line DM-4601 Nasal/Oral O2 and CO2 Sampling Cannula CO2-MAS Capnomask O2 + CO2 Sampling Mask DM-4000 Nasal CO2 Sampling Cannula w/ O2 Delivery oxygen mask mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-05-22
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2015-02-16
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2016-04-20

Official Correspondent

NC Leow

US Agent Details

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

Related Public Records

Same Entity

Dispo-Med (MALAYSIA) 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
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710116. Last updated year: 2026. Please use registration number 9710116 when referencing this establishment in official correspondence.