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Organization name
UDI-DI code
Reference / catalog number

Orthèse de cheville gel — Class I MDR by ORTHOMEDICA

MD Atlas
ORTHOMEDICA

EUDAMED last updated this device on May 13, 2026

Orthèse de cheville gel

3665012CHEVILLEV5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTHOMEDICA
UDI-DI code: 03665012000317
Reference / catalog number: 7100136

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Manufacturer information

Organization name: ORTHOMEDICA
SRN: FR-MF-000001811
Manufacturer status: Active

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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.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	May 13, 2026	Still on market

Device identification

Trade name: Orthèse de cheville gel
UDI-DI code: 03665012000317
Basic UDI-DI: 3665012CHEVILLEV5
Reference / catalog number: 7100136
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: Orthèse passive de cheville-pied destinée à la stabilisation de la cheville.
Additional information URL: https://www.orthomedica.fr/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y06120601PASSIVE ANKLE-FOOT ORTHOSES

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

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Expiration date
Manufacturing date
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Software identification