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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 CAST PACK — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Jul 31, 2024

CRYOSTAB CAST PACK

37014598PIECRY011STLX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03701459811021
Reference / catalog number: CRYOSTAB CAST 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 CAST PACK
UDI-DI code: 03701459811021
Basic UDI-DI: 37014598PIECRY011STLX
Reference / catalog number: CRYOSTAB CAST 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: Manchon interne amovible recouvrant l’intégralité de la cheville. Rembourrage mousse infra-malléolaire, ayant un effet antalgique et sur la résorption de l’œdème. Fermeture par auto-agrippant après passage des sangles dans les encoches des coques latérales favorisant un serrage optimal. Attelle prête à l’emploi, mais possibilité d’adaptation à toutes les morphologies : Positionnement préalable du manchon ; Application des coques latérales en respectant l’asymétrie des malléoles. Manchon de pied pour bloquer le pied à 90°. L’attelle CryoStab® CAST est livrée avec 2 compresses de froid CryoStab® 9X18. L’ensemble CryoStab® CAST PACK est composé de l’attelle CryoStab® CAST (livrée avec deux compresses CryoStab® 9X18) et d’un CryoStab® RACK 9X18.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: ADULTE - HAUTEUR COQUE 25.5CM

EMDN nomenclature code(s)

Y06120601PASSIVE ANKLE-FOOT 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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