Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033363705

FEI Number

3033363705

Entity Name

BLUE ELEPHANT.CO.,LTD.

City/State/Country

Seongdong-gu Seoul, KR

Establishment Address

5F 8, Achasan-ro 5-gil, Seongdong-gu Seoul 04793, KR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility,Foreign Private Label Distributor

Owner / Operator

BLUE ELEPHANT.CO.,LTD. (Owner Number: 10094276)

Owner / Operator Contact Address

5F 8, Achasan-ro 5-gil, Seongdong-gu, KR-11 04793, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BLUE ELEPHANT BLUE ELEPHANT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2025-11-20
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2025-11-20

Official Correspondent

Jieun Bae

US Agent Details

Seoyoung Yang Business: BLUEELEPHANT USA, INC Email: youni@blueelephant.co Phone: (213) 8728225

Related Public Records

Same Entity

BLUE ELEPHANT.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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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 3033363705. Last updated year: 2026. Please use registration number 3033363705 when referencing this establishment in official correspondence.