FDA.reportPublic FDA data

Fielmann

Primary DI
04066209053588
Brand
Fielmann
Company
Fielmann Group AG
Model
LN 058 FLEX CL CODY_28036
Published
2025-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQZFrame, Spectacle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04066209053588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04066209053588040662090535884066209053588

GMDN Terms#

Term, Definition table
TermDefinition
Spectacle frameAn ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
312583602
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04066209038196FielmannMF 053 SUN FA_237762026-07-06
04066209038202FielmannMF 054 SUN FA_237772026-07-06
04066209038219FielmannMF 054 SUN FA_237782026-07-06
04066209052154FielmannABC 078 FLEX CL_278932026-07-06
04066209052161FielmannABC 078 FLEX CL_278942026-07-06
04066209052178FielmannABC 084 FA BLANCA_278662026-07-06
04066209052253FielmannABC 086 FA PALOMA_278822026-07-06
04066209052284FielmannABC 087 FA LUISA_278792026-07-06
04066209053885FielmannLD 036 SUN CL JASMIN_280822026-07-06
04066209060180FielmannMC 645 SUN FA FIONA_290292026-07-06
04066209060197FielmannMC 645 SUN FA FIONA_290262026-07-06
04066209060203FielmannMC 646 SUN FA BROOKE_290382026-07-06
04066209060265FielmannMC 649 SUN CL BLAKE_291012026-07-06
04066209060289FielmannMC 650 SUN FA LUCIA_290372026-07-06
04066209060388FielmannQ 083 SUN FLEX CL TANI_290652026-07-06
04066209060470FielmannQ 085 SUN FLEX CL YORI_290702026-07-06
04066209060845FielmannLN 083 SUN FA ALBA_291392026-07-06
04066209061132FielmannBD 599 SUN CL TONI II_291762026-07-06
04066209063570FielmannAB 015 SUN RN ROMEO_295152026-07-06
04066209064416FielmannJIL 010 SUN CL_200082026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066209052154FielmannFielmann Group AGHQZ2026-07-06
04066209052161FielmannFielmann Group AGHQZ2026-07-06
04066209052178FielmannFielmann Group AGHQZ2026-07-06
04066209052253FielmannFielmann Group AGHQZ2026-07-06
04066209052284FielmannFielmann Group AGHQZ2026-07-06
08435304380985ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304381944ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304375615ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375622ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375639ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304379262ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388721ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388745ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304355259ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355266ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355273ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355310ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355327ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304361915ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361953ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361052ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361090ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361113ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361137ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361175ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-16
08435304361977ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304361991ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304388806ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304389858ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304379279ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04