Engineered Medical Systems Malaysia Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Engineered Medical Systems Malaysia Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3011503227
FEI Number3011503227
NameEngineered Medical Systems Malaysia sdn. Bhd.
Owner & OperatorENGINEERED MEDICAL SYSTEMS
Contact Address2055 EXECUTIVE DR. --
INDIANAPOLIS IN 46241 US
Official Correspondent
  • TAMARA - LEFEVERS
  • x-317-2465500-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address993,Lorong Perindustrian Bukit Minyak 11 Taman Perindustrian Bukit Minyak
Simpang Ampat Pulau Pinang, 14000 MY
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
Aero-T2018-06-19
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
Aero-T+2018-06-19
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
Aero-Sat2018-06-19
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
O2-MAX2008-12-09
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
O2 Resq2008-12-09
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
Go-PAP2008-12-09
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
AccuPAP2008-12-09
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
VentiSure22007-12-04
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
FENEM2007-12-04
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
Aero-Sat2007-12-04
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
Aero-Pro2007-12-04
Engineered Medical Systems Malaysia sdn. Bhd. [ENGINEERED MEDICAL SYSTEMS]
DPM2007-12-04

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