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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 CHEILLE MOBISTAB GAMME… — Class I MDR by MEDISPORT

MD Atlas
MEDISPORT

EUDAMED last updated this device on Apr 15, 2026

ORTHESE DE CHEILLE MOBISTAB GAMME ORTHOMARINE

3664617CHV15UA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDISPORT
UDI-DI code: 03664617009282
Reference / catalog number: 816.020

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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 DE CHEILLE MOBISTAB GAMME ORTHOMARINE
UDI-DI code: 03664617009282
Basic UDI-DI: 3664617CHV15UA
Reference / catalog number: 816.020
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: Chevillière à lacets munie de renforts latéraux assurant la stabilité de la cheville. Un seul point d’attache comprenant les lacets regroupés permet la mise en place rapide de l’orthèse, 2 sangles élastiques viennent renforcer le maintien par effet de strapping. Modèle bilatéral - Taille 2
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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Expiration date
Manufacturing date
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Software identification