Insulet Malaysia Sdn. Bhd.

FDA Device Registration & Listing · Iskandar Puteri Johor, MY · Registration 3030970576

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030970576
FEI Number
3030970576
Entity Name
Insulet Malaysia Sdn. Bhd.
City/State/Country
Iskandar Puteri Johor, MY
Establishment Address
No.5, Jalan Persiaran Bioteknologi, Kawasan Perindustrian SILC, Iskandar Puteri Johor 79200, MY
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
INSULET CORPORATION (Owner Number: 9056196)
Owner / Operator Contact Address
100 Nagog Park, --, Acton, MA 01720, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Omnipod 5 Pod

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QFG Alternate Controller Enabled Insulin Infusion Pump Clinical Chemistry Class 2 880.5730 2023-11-27

Official Correspondent

Chuck Medovich

US Agent Details

Laetitia Cousin Business: INSULET CORPORATION Email: RegulatoryAffairs@Insulet.com Phone: (978) 6007825

Related Public Records

Same Entity

INSULET CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014585508 Insulet Corporation Acton, MA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030970576. Last updated year: 2026. Please use registration number 3030970576 when referencing this establishment in official correspondence.
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