Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038613760

FEI Number

3038613760

Entity Name

GT2 HEALTHCARE SDN.BHD.

City/State/Country

Kulim Kedah, MY

Establishment Address

Lot 5-3, Jalan Hi-Tech 6, Zon Industri Fasa 2, Kulim Hi-Tech Park, Kulim Kedah 09000, MY

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

GT2 HEALTHCARE SDN.BHD. (Owner Number: 10093482)

Owner / Operator Contact Address

Lot 5-3, Jalan Hi-Tech 6, Zon Industri Fasa 2, Kulim Hi-Tech Park, Kulim, MY-02 09000, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bronchoscope (flexible or rigid)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-05-22

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants Inc Email: info@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

GT2 HEALTHCARE SDN.BHD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038613760. Last updated year: 2026. Please use registration number 3038613760 when referencing this establishment in official correspondence.