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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

CRYOSTAB® WALK’AIR — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Jan 17, 2024

CRYOSTAB® WALK’AIR

376003544PIECRY004STH4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03760035449348
Reference / catalog number: CRYOSTAB® WALK’AIR

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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 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® WALK’AIR
UDI-DI code: 03760035449348
Basic UDI-DI: 376003544PIECRY004STH4
Reference / catalog number: CRYOSTAB® WALK’AIR
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: Système pneumatique d’immobilisation et de contention progressif et dégressif permettant de s’adapter facilement à un changement de volume du pied (œdème). Disponible en 2 hauteurs. Permet l’immobilisation de la cheville à 90° et du coup de pied ainsi que du tibia et du péroné. 2 coques rigides pour une immobilisation optimale. Talonnette de compensation optionnelle. Modèle bilatéral. Taille haute : 43,2 cm de haut. Taille basse : 22,9 cm de haut. L’ensemble CryoStab® WALK’AIR est composé de la botte de marche STABIBOOT’AIR BASSE/HAUTE et de deux compresses CryoStab® 14X14. L’ensemble CryoStab® WALK’AIR Pack est composé de la botte de marche STABIBOOT’AIR BASSE/HAUTE, de deux compresses CryoStab® 14X14 et d’un CryoStab® RACK 14X14. Absence de latex, de phtalates (DHP), de nickel, de produit d’origine animale ou biologique.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: T3/L - BASSE - POINTURE : 41-44

EMDN nomenclature code(s)

Y063303READY-MADE ORTHOTIC SHOES

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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