FDA.reportPublic FDA data

E5 eyevan

Primary DI
04582669068318
Brand
E5 eyevan
Company
EYEVAN INC.
Model
P30E 48 DM
Published
2026-07-10
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
04582669068318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582669068318045826690683184582669068318

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
705184505
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
04580822703694EYEVANFOUNTAIN 50 AG2026-07-10
04580822703724EYEVANFOUNTAIN 50 RG2026-07-10
04580822703731EYEVANFOUNTAIN 50 S2026-07-10
04580822703748EYEVANFOUNTAIN 50 YG2026-07-10
04580822704165EYEVANMATEO-E 53 MPBK-D.MST.FADE2026-07-10
04580822704172EYEVANMATEO-E 53 PBKS-MD.GY2026-07-10
04580822704189EYEVANMATEO-E 53 PBKG-S.BR2026-07-10
04580822704196EYEVANMATEO-E 53 TORT-GRY2026-07-10
04580822704264EYEVANWEBB SQ(49)-E 49 BKWHN2026-07-10
04580822704271EYEVANWEBB SQ(49)-E 49 ECR2026-07-10
04580822704288EYEVANWEBB SQ(49)-E 49 GPT2026-07-10
04580822704295EYEVANWEBB SQ(49)-E 49 TORT2026-07-10
04580822704561EYEVANSUNSET-E 57 BGN2026-07-10
04580822704578EYEVANSUNSET-E 57 LSMK2026-07-10
04580822704585EYEVANSUNSET-E 57 PBKS2026-07-10
04580822704592EYEVANSUNSET-E 57 TORT2026-07-10
04580822704660EYEVANSUNSET-E 57 BGN-GRY2026-07-10
04580822704677EYEVANSUNSET-E 57 CRL-P.BLUH2026-07-10
04580822704684EYEVANSUNSET-E 57 LLT-D.MST.FADE2026-07-10
04580822704691EYEVANSUNSET-E 57 LSMK-GY.GRD22026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800348921041Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921058Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921096Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921102Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
03701629015006Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-07-21
08800348920501Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920518Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920587Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920594Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920600Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920617Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920662Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920679Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920716Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920723Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920730Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920778Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920785Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920860Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
04066209006799FielmannFielmann Group AGHQZ2026-07-14
04066209008311FielmannFielmann Group AGHQZ2026-07-14
04066209008885FielmannFielmann Group AGHQZ2026-07-14
04066209045118FielmannFielmann Group AGHQZ2026-07-14
04066209054578FielmannFielmann Group AGHQZ2026-07-14
04580822703694EYEVANEYEVAN INC.HQZ2026-07-10
04580822703724EYEVANEYEVAN INC.HQZ2026-07-10
04580822703731EYEVANEYEVAN INC.HQZ2026-07-10
04580822703748EYEVANEYEVAN INC.HQZ2026-07-10
04580822704264EYEVANEYEVAN INC.HQZ2026-07-10
04580822704271EYEVANEYEVAN INC.HQZ2026-07-10