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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 GENOU FAST EVO PACK — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Jul 15, 2024

CRYOSTAB GENOU FAST EVO PACK

37014598GENCRY018STG6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03701459810932
Reference / catalog number: CRYOSTAB GENOU FAST EVO PACK

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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: CRYOSTAB GENOU FAST EVO PACK
UDI-DI code: 03701459810932
Basic UDI-DI: 37014598GENCRY018STG6
Reference / catalog number: CRYOSTAB GENOU FAST EVO PACK
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 prête à l’emploi munie de 2 articulations monocentriques métalliques permettant : une immobilisation complète du genou en extension (0°) ou à 20° ou une immobilisation du genou avec libération articulaire limitée par une butée anti-recurvatum. Larges bandes de fermeture pour rapidité de mise en place. Double système antiglisse. Mousse intérieure : confort optimal. Baleinages amovibles : lavables. L’ensemble CryoStab® GENOU FAST EVO est composé de l’attelle STABILIG FAST EVO & de 2 compresses de froid CryoStab® 14X28. L’ensemble CryoStab® GENOU FAST EVO PACK est composé de l’attelle STABILIG FAST EVO, de 2 compresses de froid CryoStab® 14X28 et d’un CruoStab® RACK 14X28.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: TL - H60

EMDN nomenclature code(s)

Y061299LOWER EXTREMITY ORTHOSES - OTHER

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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