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Organization name
UDI-DI code
Reference / catalog number

CRYOSTAB® POIGNET UNIVERSEL — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Jan 12, 2024

CRYOSTAB® POIGNET UNIVERSEL

376003544POICRY003STR9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03760035444305
Reference / catalog number: CRYOSTAB® POIGNET UNIVERSEL

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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 UNIVERSEL
UDI-DI code: 03760035444305
Basic UDI-DI: 376003544POICRY003STR9
Reference / catalog number: CRYOSTAB® POIGNET UNIVERSEL
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 permet à la fois le maintien du poignet et du pouce par l’ajout d’une baleine de pouce amovible et une application de froid sur la partie lésée apportant un effet antalgique, une réduction de l’inflammation et/ou de l’œdème. Possède une éclisse palmaire intégrée à l’attelle et une éclisse dorsale amovible. L’attelle est livrée avec une compresse CryoStab® 14X14. L’ensemble CryoStab® POIGNET UNIVERSEL Pack est composé d’un STABIPOIGNET UNIVERSEL et d’un CryoStab® RACK 14X14. Composition : Polyamide, polyacétal, polyoxyméthylène, polypropylène, Tetoron, nylon, Spandex, polyuréthane, polyester, polytéréphtalate de butylène, élasthanne, acrylique, coton, acier, aluminium. 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: TU - AMBIDEXTRE

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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