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Organization name
UDI-DI code
Reference / catalog number

CRYOSTAB® OMNI-WALKER — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Jan 17, 2024

CRYOSTAB® OMNI-WALKER

376003544PIECRY005STH9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03760035447573
Reference / catalog number: CRYOSTAB® OMNI-WALKER

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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® OMNI-WALKER
UDI-DI code: 03760035447573
Basic UDI-DI: 376003544PIECRY005STH9
Reference / catalog number: CRYOSTAB® OMNI-WALKER
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: Immobilisation réglable à 75°, 90°, 105° ou 120° (sur indication du médecin uniquement). Semelle externe convexe antidérapante : déroulé du pas sans mobilisation de la cheville et sans déséquilibre latéral. Système d’attache et de fixation du chausson sur la semelle. Chausson amovible / lavable : mousse intérieure rembourrée au niveau des malléoles. Évasement malléolaire et évidement au niveau du tendon d’Achille. L’ensemble CryoStab® OMNI-WALKER est composé de la botte OMNI-WALKER & de deux compresses de froid CryoStab® 14X14. L’ensemble CryoStab® OMNI-WALKER Pack est composé de la botte OMNI-WALKER, de deux compresses de froid CryoStab® 14X14 & d’un CryoStab® PACK 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 - DROITE - POINTURE : 41-43

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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