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Organization name
UDI-DI code
Reference / catalog number

CRYOSTAB® ELBOW 90° PACK — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Jan 12, 2024

CRYOSTAB® ELBOW 90° PACK

376003544MACCRY001ST52

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03760035446705
Reference / catalog number: CRYOSTAB® ELBOW 90° 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® ELBOW 90° PACK
UDI-DI code: 03760035446705
Basic UDI-DI: 376003544MACCRY001ST52
Reference / catalog number: CRYOSTAB® ELBOW 90° 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: La STABICOUD MODULO est une attelle de coude ambidextre intégrant un baleinage palmaire et dorsal en aluminium modelable et amovible permettant une immobilisation du coude et de l’articulation du poignet. Une sangle d’épaule réglable et amovible complète le dispositif. Elle assure une position antalgique et évite la rotation du poignet. L’ensemble CryoStab® ELBOW 90° est composé d’une STABICOUD MODULO et de deux compresses CryoStab® 14X14. L’ensemble CryoStab® ELBOW 90° Pack est composé d’une STABICOUD MODULO, de deux compresses CryoStab® 14X14 et d’un CryoStab® RACK 14X14. Composition : Polyacétal, polyoxyméthylène, nylon, polyamide, polyester, polyuréthane, coton, 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: TM - AMBIDEXTRE - LONGUEUR AVANT-BRAS : 31CM

EMDN nomenclature code(s)

Y060619ELBOW-WRIST-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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