Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003902965

FEI Number

3003902965

Entity Name

Texstrip Manufacturing SDN.BHD.

City/State/Country

Darul Ehsan Selangor, MY

Establishment Address

Lot 1908, Batu 7, Jalan Bukit Kemuning, Darul Ehsan Selangor 42450, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Texstrip Manufacturing SDN.BHD. (Owner Number: 10028963)

Owner / Operator Contact Address

Lot 1908, Batu 7, Jalan Bukit Kemuning, Shah Alam, MY-10 40470, MY

Initial Importer Flag

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	2011-05-20

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

Texstrip Manufacturing SDN.BHD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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3030461038	PLASTICOSCRT, S.A. DE C.V.	Santa Catarina Nuevo Leon, MX
3014146184	WHEELSTONE ENTERPRISE CO., LTD.	Taichung City, TW
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003902965. Last updated year: 2026. Please use registration number 3003902965 when referencing this establishment in official correspondence.