FDA Registration Active 🇲🇾 Malaysia

DISPO-MED (MALAYSIA) SDN BHD

Reg #: 9710116 · FEI: 3003348851 · Expires 2026
Products
3
Proprietary Names
16
Establishment Types
1
Classifications
3

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Registration Details

Registration Name
DISPO-MED (MALAYSIA) SDN BHD
Registration Number
9710116
FEI Number
3003348851
Status
Active
Expiry Year
2026
Initial Importer
No
Address
No. 3, Jalan Meteor U16/153A, Elmina, Sekysen 16
City
Shah Alam Selangor
Country
MY

Regulatory Submissions

510(k) Number
K143127

Owner / Operator

Firm Name
Dispo-Med (MALAYSIA) SDN BHD
Operator Number
10048710
Address
No. 3, Jalan Meteor U16/153A, Elmina, Sekysen 16
City
Shah Alam
State
Selangor
Postal Code
40160
Country
MY
Correspondent
NC Leow

US Agent

Business Name
ProMedic, LLC
Contact Name
Matt Dryden Dryden
Address
131 Bay Point Dr NE
City
Saint Petersburg
State
FL
ZIP
33704
Country
US
Phone
239 3076063

Products

Device Name Product Code
Accessory, Surgical Apparel LYU
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
Mask, Oxygen BYG

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

Establishment Types

Manufacture Medical Device