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Organization name
UDI-DI code
Reference / catalog number

STABICAST DYNAMIQUE — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on May 27, 2024

STABICAST DYNAMIQUE

37014598CHEIMM019ST4Q

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03701459810819
Reference / catalog number: STABICAST DYNAMIQUE

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Manufacturer information

Organization name: GROUPE SOBER SAS
SRN: FR-MF-000017818
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.

CW018
Consulter les précautions d’emploi et méthode de pose avant utilisation.

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: STABICAST DYNAMIQUE
UDI-DI code: 03701459810819
Basic UDI-DI: 37014598CHEIMM019ST4Q
Reference / catalog number: STABICAST DYNAMIQUE
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: Le STABICAST DYNAMIQUE est bilatéral et seraS porté avec une chaussure. Attelle facile à positionner sur le pied grâce à sa fermeture postérieure à glissière. Matériau ventilé léger pour un confort d'utilisation maximal et un ajustement parfait avec une chaussure. Les sangles de type croisé offrent un soutien et une pression supplémentaires. Le système BOA® offre une compression et une stabilisation micro-réglables sur la voûte plantaire et la cheville. Le système BOA® offre à l'utilisateur un moyen simple de tourner le cadran pour obtenir la compression souhaitée par le patient. Présence de deux armatures en plastique latérales et médiales. Présence d’une sangle élastique amovible pour maintenir le pied relevé. Deux armatures latérales en aluminium empêchent l’inflammation et les entorses d’introversion et d’extraversion de l’articulation de la cheville et minimisent sa nouvelle blessure.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: T3 - HT 17CM - TOUR DE CHEVILLE 26-30CM

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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