Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042895304

FEI Number

3042895304

Entity Name

MARCO OPTICAL (THAILAND) COMPANY LIMITED

City/State/Country

Ban Bueng Chon Buri, TH

Establishment Address

447/65, Mu 3, Nong Phai Kaeo Sub-district, Ban Bueng Chon Buri 20220, TH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

MARCO OPTICAL (THAILAND) COMPANY LIMITED (Owner Number: 10094655)

Owner / Operator Contact Address

447/65, Mu 3, Nong Phai Kaeo Sub-district, Ban Bueng, TH-20 20220, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sunglasses Optical Frame Shields, protective Eyeshields Reading glasses

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2025-12-14
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2025-12-14
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2025-12-14
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2025-12-14
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2025-12-14

Official Correspondent

Jane Liu

US Agent Details

James St. WU Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

MARCO OPTICAL (THAILAND) COMPANY LIMITED

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
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
K853921	Winsburn Company , Ltd.	ALL KINDS OF SUNGLASSES	1985-10-15

Similar Registrations

Registration Number	Establishment Name	Location
3007009595	RAEN OPTICS	Oceanside, CA, US
3008137594	CHLOE SAS	PARIS Ile-de-France, FR
3042870833	GOLEADER(VIETNAM) RECREATION LIMITED	Tan Phuoc 3 Commune Dong Thap, VN
3009141079	STAGE	Sandy, UT, US
3013857947	FARFETCH ITALIA S.R.L.	MILAN Milano, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042895304. Last updated year: 2026. Please use registration number 3042895304 when referencing this establishment in official correspondence.