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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 CHEVILLE STANDARD GAMME… — Class I MDR by MEDISPORT

MD Atlas
MEDISPORT

EUDAMED last updated this device on Apr 16, 2026

ORTHESE CHEVILLE STANDARD GAMME ORTHOMARINE

3664617CHV01TX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDISPORT
UDI-DI code: 03664617007820
Reference / catalog number: 812.005

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Manufacturer information

Organization name: MEDISPORT
SRN: FR-MF-000000677
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.

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 CHEVILLE STANDARD GAMME ORTHOMARINE
UDI-DI code: 03664617007820
Basic UDI-DI: 3664617CHV01TX
Reference / catalog number: 812.005
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 2 coques latérales anatomiques recouvertes d’un capitonnage interne hypoallergénique en mousse. Taille Enfant
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

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