INNOVATE MEDICAL MALAYSIA, SDN. BHD.

FDA Device Registration & Listing · Shah Alam Selangor, MY · Registration 3027555965

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
3027555965
FEI Number
3027555965
Entity Name
INNOVATE MEDICAL MALAYSIA, SDN. BHD.
City/State/Country
Shah Alam Selangor, MY
Establishment Address
7, Jalan Anggerik Mokara 31-45, Kota Kemuning, Shah Alam Selangor 40460, MY
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
INNOVATE MEDICAL MALAYSIA, SDN. BHD. (Owner Number: 10088320)
Owner / Operator Contact Address
7, Jalan Anggerik Mokara 31-45, Kota Kemuning, Shah Alam, MY-10 40460, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2023-06-28

Official Correspondent

No official correspondent registered.

US Agent Details

Susan Johnston Business: Innovate Medical, LLC Email: susanj@innovatemed.com Phone: (423) 4613558

Related Public Records

Same Entity

INNOVATE MEDICAL MALAYSIA, SDN. BHD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027555965. Last updated year: 2026. Please use registration number 3027555965 when referencing this establishment in official correspondence.
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