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E5 eyevan

EUDAMED

Class I (EU MDR)

Ref P4 48 DMAGModel Plastic/Combination

by EYEVAN Inc.

Identity

Trade Name
E5 eyevan EUDAMED
Device Name
Metal and plastic spectacle frames without lenses EUDAMED
Model / Reference
Plastic/Combination EUDAMED
P4 48 DMAG EUDAMED

Identifiers

Primary DI / UDI-DI
04571445031295 EUDAMED
Basic UDI-DI
457144503RXCMBEK EUDAMED
EMDN Code
Q02100203 METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

E5 eyevan by Eyevan Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
EYEVAN Inc.
EUDAMED SRN
JP-MF-000028437
Authorised Representative
EYEVAN Europe FR-AR-000025678

Sources (1)

  • EUDAMED d9653f6c-2903-4f67-b768-d5f62bd69d4d 61 fields · synced May 22, 2026