Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034427874

FEI Number

3034427874

Entity Name

PT GRAHA ELEKTRINDO PERKASA

City/State/Country

Kota Tangerang Banten, ID

Establishment Address

JL MANIS 4 NOMOR 24, Desa/Kelurahan Gandasari, Kec. Jatiuwung, Kota Tangerang Banten 15137, ID

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

PT Graha Elektrindo Perkasa (Owner Number: 10093199)

Owner / Operator Contact Address

JL MANIS 4 NOMOR 24, Desa/Kelurahan Gandasari, Kec. Jatiuwung, Kota Tangerang, ID-BT 15137, ID

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
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2025-04-13
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2025-04-13
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2025-04-13
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2025-04-13

Official Correspondent

Thomas Pang

US Agent Details

Thomas Pang Business: kapo optik Email: kapo_optik@yahoo.com Phone: (626) 2266699

Related Public Records

Same Entity

PT Graha Elektrindo Perkasa

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
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06

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3009554831	ROGER EYE DESIGN	Etten-Leur Noord-Brabant, NL
3013507321	DEM FACTORY S.R.L.	Limana Belluno, IT
3015243992	L.G.R SRL	Roma, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034427874. Last updated year: 2026. Please use registration number 3034427874 when referencing this establishment in official correspondence.