FDA.reportPublic FDA data

E5 eyevan

Primary DI
04582669059859
Brand
E5 eyevan
Company
EYEVAN INC.
Model
P25E 49 DM
Published
2025-11-15
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
04582669059859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582669059859045826690598594582669059859

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
705184505
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582669045456IVRIOTIVT201 54 2030-CL2026-03-26
04582669045463IVRIOTIVT201 54 1020-CL2026-03-26
04582669045470IVRIOTIVT201 54 3000-CL2026-03-26
04582669045487IVRIOTIVT201 54 1000-GY PH2026-03-26
04582669045494IVRIOTIVT201 54 2030-PK PH2026-03-26
04582669045500IVRIOTIVT201 54 1020-BL PH2026-03-26
04582669045517IVRIOTIVT201 54 3000-BR PH2026-03-26
04582669045531IVRIOTIVT202 51 1000-CL2026-03-26
04582669045548IVRIOTIVT202 51 2030-CL2026-03-26
04582669045555IVRIOTIVT202 51 1020-CL2026-03-26
04582669045562IVRIOTIVT202 51 3040-CL2026-03-26
04582669045579IVRIOTIVT202 51 1000-GY PH2026-03-26
04582669045586IVRIOTIVT202 51 2030-GY PH2026-03-26
04582669045593IVRIOTIVT202 51 1020-PK PH2026-03-26
04582669045609IVRIOTIVT202 51 3040-BL PH2026-03-26
04582669032869IVRIOTIVT100 48 101-CL2026-03-25
04582669032876IVRIOTIVT100 48 102-CL2026-03-25
04582669032890IVRIOTIVT101 49 101-CL2026-03-25
04582669032906IVRIOTIVT101 49 102-CL2026-03-25
04582669032920IVRIOTIVT102 50 101-CL2026-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066209026032FielmannFielmann Group AGHQZ2026-07-08
04066209033016FielmannFielmann 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