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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 — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Jul 5, 2024

CRYOSTAB® GENOU

376003544GENCRY001STA55

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03701459810833
Reference / catalog number: CRYOSTAB® GENOU

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Manufacturer information

Organization name: GROUPE SOBER SAS
SRN: FR-MF-000017818
Manufacturer status: Active

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
UDI-DI code: 03701459810833
Basic UDI-DI: 376003544GENCRY001STA55
Reference / catalog number: CRYOSTAB® GENOU
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: Genouillère articulée gonflable avec pompe amovible et froid CryoStab®. Genouillère anatomique dotée d’une ouverture totale et d’un évidement rotulien. Fermeture par 2 sangles distinctes qui facilitent la mise en place du produit même en présence de pansement. Apporte un effet antalgique rapide et permet une réduction de l’œdème et de l’inflammation, ce qui permet de faciliter la rééducation. Version Plus : Baleinage latéral amovible. L’attelle CryoStab® GENOU est livrée avec 2 compresses de froid CryoStab® 14X28. L’ensemble CryoStab® GENOU PACK est composé de l’attelle CryoStab® GENOU (livrée avec deux compresses CryoStab® 14X28) et d’un CryoStab® RACK 14X28.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: TU

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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