Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011367352

FEI Number

3011367352

Entity Name

ORGREEN GOLDSMITH

City/State/Country

Berkeley, CA, US

Establishment Address

2607 7th St Ste E, Berkeley, CA 94710, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Orgreen Goldsmith (Owner Number: 10049269)

Owner / Operator Contact Address

2607 7th Street, Suite E, Berkeley, CA 94710, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Claire Goldsmith Orgreen Optics Denmark Orgreen Optics Denmark

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2018-02-09
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2018-02-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Orgreen Goldsmith

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 3011367352. Last updated year: 2026. Please use registration number 3011367352 when referencing this establishment in official correspondence.