Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012267379

FEI Number

3012267379

Entity Name

BLOOMDALE EYEWEAR

City/State/Country

Rosmalen Noord-Brabant, NL

Establishment Address

Kievitsven, 80, Rosmalen Noord-Brabant 5249JK, NL

Establishment Type(s)

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

Owner / Operator

Bloomdale Eyewear (Owner Number: 10092258)

Owner / Operator Contact Address

Kievitsven, 80, Rosmalen, NL-NB 5249JK, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Metal frames Acetate frames

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2024-12-18

Official Correspondent

Armand Van Lingen

US Agent Details

Eckhard Wirtz Business: BrillenEyes Email: eckhard.wirtz@brilleneyes.com Phone: (949) 2159661

Related Public Records

Same Entity

Bloomdale Eyewear

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

Similar Registrations

Registration Number	Establishment Name	Location
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 3012267379. Last updated year: 2026. Please use registration number 3012267379 when referencing this establishment in official correspondence.