FDA.reportPublic FDA data

Fielmann

Primary DI
04066209033016
Brand
Fielmann
Company
Fielmann Group AG
Model
COMFORT 117 CL_22704
Published
2026-07-08
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
HQZFrame, Spectacle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04066209033016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04066209033016040662090330164066209033016

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).

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
04066209026032FielmannMI 029 CL_211372026-07-08
04066209033184FielmannJIL 018 CL_227602026-07-08
04066209040083FielmannTITANIUM 199 FLEX CL_241612026-07-08
04066209044883FielmannMF 057 RN_251652026-07-08
04066209046917FielmannCOMFORT 129 FLEX CL_254232026-07-08
04066209046924FielmannCOMFORT 129 FLEX CL_254232026-07-08
04066209047051FielmannJIL 009 CL_254272026-07-08
04066209049178FielmannTITANIUM 206 CL UWE_257452026-07-08
04066209051140FielmannJIL 033 FLEX CL_276092026-07-08
04066209051201FielmannJIL 032 FLEX CL_276182026-07-08
04066209052475FielmannBE 032 FA_279342026-07-08
04066209052673FielmannABC 080 FLEX CL KIM_279762026-07-08
04066209052697FielmannABC 080 FLEX CL KIM_279752026-07-08
04066209052932FielmannABC 079 FLEX FA AMANDA_279852026-07-08
04066209055445FielmannABC 090 FLEX CL ANDREA_282922026-07-08
04066209055803FielmannMF 059 RN CLAUDIA_283542026-07-08
04066209056213FielmannABC 092 FA EMMA_283972026-07-08
04066209058637FielmannABC 097 FLEX FA JESSICA_287452026-07-08
04066209058644FielmannABC 097 FLEX FA JESSICA_287432026-07-08
04066209058934FielmannMF 061 RN GIGI_288432026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066209026032FielmannFielmann Group AGHQZ2026-07-08
04066209033184FielmannFielmann Group AGHQZ2026-07-08
04066209040083FielmannFielmann Group AGHQZ2026-07-08
04066209044883FielmannFielmann Group AGHQZ2026-07-08
04066209046917FielmannFielmann Group AGHQZ2026-07-08
04066209046924FielmannFielmann Group AGHQZ2026-07-08
04066209047051FielmannFielmann Group AGHQZ2026-07-08
04066209049178FielmannFielmann Group AGHQZ2026-07-08
04066209051140FielmannFielmann Group AGHQZ2026-07-08
04066209051201FielmannFielmann Group AGHQZ2026-07-08
04066209052475FielmannFielmann Group AGHQZ2026-07-08
04066209052673FielmannFielmann Group AGHQZ2026-07-08
04066209052697FielmannFielmann Group AGHQZ2026-07-08
04066209052932FielmannFielmann Group AGHQZ2026-07-08
04066209055445FielmannFielmann Group AGHQZ2026-07-08
04066209055803FielmannFielmann Group AGHQZ2026-07-08
04066209056213FielmannFielmann Group AGHQZ2026-07-08
04066209058637FielmannFielmann Group AGHQZ2026-07-08
04066209058644FielmannFielmann Group AGHQZ2026-07-08
04066209058934FielmannFielmann Group AGHQZ2026-07-08
04066209059795FielmannFielmann Group AGHQZ2026-07-08
04066209060074FielmannFielmann Group AGHQZ2026-07-08
04066209060081FielmannFielmann Group AGHQZ2026-07-08
04066209060425FielmannFielmann Group AGHQZ2026-07-08
04066209060487FielmannFielmann Group AGHQZ2026-07-08
04066209060517FielmannFielmann Group AGHQZ2026-07-08
04066209063525FielmannFielmann Group AGHQZ2026-07-08
04066209063600FielmannFielmann Group AGHQZ2026-07-08
03701629014160Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-07-07
03701629014177Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-07-07