FDA.reportPublic FDA data

Fielmann

Primary DI
04066209060265
Brand
Fielmann
Company
Fielmann Group AG
Model
MC 649 SUN CL BLAKE_29101
Published
2026-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04066209060265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04066209060265040662090602654066209060265

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Regulatory Flags#

DUNS number
312583602
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
04066209064430FielmannJIL 020 SUN CL_232012026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066209038196FielmannFielmann Group AGHQY2026-07-06
04066209038202FielmannFielmann Group AGHQY2026-07-06
04066209038219FielmannFielmann Group AGHQY2026-07-06
04066209053885FielmannFielmann Group AGHQY2026-07-06
04066209060180FielmannFielmann Group AGHQY2026-07-06
04066209060197FielmannFielmann Group AGHQY2026-07-06
04066209060203FielmannFielmann Group AGHQY2026-07-06
04066209060289FielmannFielmann Group AGHQY2026-07-06
04066209060388FielmannFielmann Group AGHQY2026-07-06
04066209060470FielmannFielmann Group AGHQY2026-07-06
04066209060845FielmannFielmann Group AGHQY2026-07-06
04066209061132FielmannFielmann Group AGHQY2026-07-06
04066209063570FielmannFielmann Group AGHQY2026-07-06
04066209064416FielmannFielmann Group AGHQY2026-07-06
04066209064430FielmannFielmann Group AGHQY2026-07-06
04066209064874FielmannFielmann Group AGHQY2026-07-06
06973541158131SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-07-06
16973541158138SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-07-06
06974213566148MalibuWENZHOU TIDE-OPTICAL CO.,LTDHQY2026-07-03
06973541158315SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158322SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158339SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158346SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
08800332269951Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-02
00676190876697Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876734Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876772Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539937Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539975Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814540018Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01