Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000308604

FEI Number

3000308604

Entity Name

Fielmann Group AG

City/State/Country

Hamburg, DE

Establishment Address

Fuhlsbuttler Str. 399, Hamburg 22309, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Fielmann USA (Owner Number: 10089548)

Owner / Operator Contact Address

700 Pilgram Way, Green Bay, WI 54304, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fielmann Qvido Fielmann

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	2023-12-19
HLG	Pupillometer, Ac-Powered	Ophthalmic	Class 1	886.1700	2025-12-03
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2023-12-15

Official Correspondent

Ed Azer

US Agent Details

Ed Azer Business: Fielmann Group AG Email: ed.azer@fielmann.com Phone: (513) 6860331

Related Public Records

Same Entity

Fielmann USA

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

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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 3000308604. Last updated year: 2026. Please use registration number 3000308604 when referencing this establishment in official correspondence.