Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038279561

FEI Number

3038279561

Entity Name

EMMA OPTIC (THAILAND) COMPANY LIMITED

City/State/Country

Khlong Luang District Pathum Thani, TH

Establishment Address

75/23, Mu 11, Khlong Nueng Sub-district,, Khlong Luang District Pathum Thani 12120, TH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EMMA OPTIC (THAILAND) COMPANY LIMITED (Owner Number: 10093400)

Owner / Operator Contact Address

75/23, Mu 11, Khlong Nueng Sub-district,, Khlong Luang District, TH-13 12120, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Isolation Boots Face Shield Mask, Face Mask, Nonwoven Face Mask, Disposable Medical Face Mask Isolation gown Spectacle frames Optical frames Sunglasses Reading Glasses

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-05-11
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2025-05-11
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2025-05-11
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2025-05-11
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2025-05-11

Official Correspondent

No official correspondent registered.

US Agent Details

Dike Yu Email: fdaamerican@gmail.com Phone: (347) 9186666

Related Public Records

Same Entity

EMMA OPTIC (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
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

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038279561. Last updated year: 2026. Please use registration number 3038279561 when referencing this establishment in official correspondence.