Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033465643

FEI Number

3033465643

Entity Name

SKANS APS

City/State/Country

Copenhagen Hovedstaden, DK

Establishment Address

Dybbolsgade 27 4th, Copenhagen Hovedstaden 1721, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Skans ApS (Owner Number: 10094599)

Owner / Operator Contact Address

Dybbolsgade 27 4th, Copenhagen, DK-84 1721, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Skans Eyewear Skans Sunglasses

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2025-12-10
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2025-12-10

Official Correspondent

Johanna Skans

US Agent Details

Lisa Wright Business: The Vision Council Email: fda@thevisioncouncil.org Phone: (703) 5484560

Related Public Records

Same Entity

Skans ApS

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

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 3033465643. Last updated year: 2026. Please use registration number 3033465643 when referencing this establishment in official correspondence.