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Organization name
UDI-DI code
Reference / catalog number

CRYOSTAB® GAC EVOLUTIV — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Jan 16, 2024

CRYOSTAB® GAC EVOLUTIV

37014598GENCRY012STF8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03701459809943
Reference / catalog number: CRYOSTAB® GAC EVOLUTIV

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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

2 warnings recorded — scroll inside the panel to see all entries.

CW018
Consulter les précautions d’emploi et méthode de pose avant utilisation.
CW999
Ne pas appliquer ce produit en cas d’hypersensibilité au froid.

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: CRYOSTAB® GAC EVOLUTIV
UDI-DI code: 03701459809943
Basic UDI-DI: 37014598GENCRY012STF8
Reference / catalog number: CRYOSTAB® GAC EVOLUTIV
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: Attelle de genou livrée avec 2 articulations monocentriques, 2 baleines postérieures (1 à 0° (code couleur noir) & 1 à 20° (code couleur gris)) et 4 sangles de fermeture amovibles (cuisse = code couleur gris) & mollet = code couleur noir). Cadrans latéraux monocentriques permettant soit : Une immobilisation de 0° à 120°, une libération articulaire (avec butée anti-recurvatum). L’ensemble CryoStab® GAC EVOLUTIV est composé de l’attelle STABILIG GAC EVOLUTIV & de deux compresses de CryoStab® 14X28. L’ensemble CryoStab® GAC EVOLUTIV Pack est composé de l’attelle STABILIG GAC EVOLUTIV, de deux compresses de CryoStab® 14X28 & d’un CryoStab® RACK 14X28). Absence de latex. Absence de phtalates. Absence de nickel. Absence de produit d’origine animale ou biologique.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: TU - H45 - TOUR DE CUISSE : 35->62CM - TOUR DE MOLLET : 26->44CM

EMDN nomenclature code(s)

Y061209KNEE 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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