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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

ORTHESE DE CHEVILLE OPEN — Class I MDR by MEDISPORT

MD Atlas
MEDISPORT

EUDAMED last updated this device on Apr 15, 2026

ORTHESE DE CHEVILLE OPEN

3664617CHV03U3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDISPORT
UDI-DI code: 03664617007684
Reference / catalog number: 814.005

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Manufacturer information

Organization name: MEDISPORT
SRN: FR-MF-000000677
Manufacturer status: Active

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW030
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: ORTHESE DE CHEVILLE OPEN
UDI-DI code: 03664617007684
Basic UDI-DI: 3664617CHV03U3
Reference / catalog number: 814.005
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 de cheville constituée de tissu élastique et respirant comprenant 2 coques latérales anatomiques. Fermeture à l’aide de 2 sangles de fixation en velours au niveau du mollet et 2 sangles de fixation en tissu au niveau du médio-pied qui viennent se positionner en se croisant sur les coques. Recommandée en cas de contact avec de l’eau. Taille Ado/Adulte
Additional information URL: No additional information URL provided by the manufacturer.
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.