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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Eden 2 — Class I MDR by Agil'Optic

MD Atlas
Agil'Optic

EUDAMED last updated this device on Jan 22, 2026

Eden 2

376043946MontureAcetateG3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Agil'Optic
UDI-DI code: 03760439460116
Reference / catalog number: 3760439460116

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Manufacturer information

Organization name: Agil'Optic
SRN: FR-MF-000048955
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: Eden 2
UDI-DI code: 03760439460116
Basic UDI-DI: 376043946MontureAcetateG3
Reference / catalog number: 3760439460116
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Monture de lunettes en plastique sans verres pour dames
Additional information URL: https://www.latelierdekaly.fr/
Clinical sizes: 50/21

EMDN nomenclature code(s)

Q02100202PLASTIC SPECTACLE FRAMES WITHOUT LENSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.