Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014452647

FEI Number

3014452647

Entity Name

PT. GAGACLO

City/State/Country

Semarang Jawa Tengah, ID

Establishment Address

1 - Jl. Tambak Aji Timur, Ngaliyan, Semarang Jawa Tengah 50185, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Red Dragon Inc. (Owner Number: 10046249)

Owner / Operator Contact Address

Room 102, No. 205, Guang Long Road,Zhongluotan Town, Bai Yun District, Guangzhou, CN-GD 510550, CN

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
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2021-01-13
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2014-02-24
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2019-04-23
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2014-02-24
IMS	Support, Head And Trunk, Wheelchair	Physical Medicine	Class 1	890.3910	2016-09-23

Official Correspondent

Ming-Hsia Lin

US Agent Details

David Frey Email: davidfrey22@gmail.com Phone: (801) 3810930

Related Public Records

Same Entity

Red Dragon Inc.

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 3014452647. Last updated year: 2026. Please use registration number 3014452647 when referencing this establishment in official correspondence.