Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012164338

FEI Number

3012164338

Entity Name

ENA OPTICAL MFG.CO.LTD

City/State/Country

NAKATSUGAWA Gifu, JP

Establishment Address

4827-48 Naegi, NAKATSUGAWA Gifu 5080101, JP

Establishment Type(s)

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

Owner / Operator

Ena Optical Mfg.co.Ltd (Owner Number: 10094817)

Owner / Operator Contact Address

4827-48 Naegi, NAKATSUGAWA, JP-21 5080101, JP

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	2025-12-25
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2025-12-25

Official Correspondent

Daisuke Niwa

US Agent Details

Avon Ray Business: Jacques Marie Mage Inc Email: avon@jacquesmariemage.com Phone: (213) 3425603

Related Public Records

Same Entity

Ena Optical Mfg.co.Ltd

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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3007521479	NY2LA INC.	Camarillo, CA, US
3005147601	VISIONTECH EXPORT INTERNATIONAL (PVT) LTD.	KARACHI Sindh, PK
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 3012164338. Last updated year: 2026. Please use registration number 3012164338 when referencing this establishment in official correspondence.