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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® POIGNET PACK — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Jan 12, 2024

CRYOSTAB® POIGNET PACK

376003544POICRY004STRE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03760035446415
Reference / catalog number: CRYOSTAB® POIGNET 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

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 les compresses 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® POIGNET PACK
UDI-DI code: 03760035446415
Basic UDI-DI: 376003544POICRY004STRE
Reference / catalog number: CRYOSTAB® POIGNET 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: L’attelle de poignet STABIPOIGNET CONFORT comprend une attelle de poignet intégrant une baleine métallique en U, modelable au niveau palmaire, dorsal et cubital et des bandes auto-agrippantes permettant de fermer l’attelle. Deux attaches auto-agrippantes papillon permettent de fixer la sangle de soutien à l’attelle. Une sangle de soutien, dotée d’un capiton de confort mobile assure un maintien optimal. L’ensemble CryoStab® POIGNET est livré avec une STABIPOIGNET CONFORT et une compresse CryoStab® 14X14. L’ensemble CryoStab® POIGNET Pack est livré avec une STABIPOIGNET CONFORT et un CryoStab® RACK 14X14. Composition : Nylon, coton, polyamide, aluminium, polyester, polyuréthane, acrylique, élastomère, polytéréphtalate de butylène, élasthanne, polyéthylène. 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: T1 - GAUCHE - LONGUEUR AVANT-BRAS : </m21CM

EMDN nomenclature code(s)

Y060612WRIST-HAND 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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