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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® STABIL’HIPS — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Nov 18, 2024

CRYOSTAB® STABIL’HIPS

37014598ABDCRY005STXN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03701459811069
Reference / catalog number: CRYOSTAB® STABIL’HIPS

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Manufacturer information

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

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® STABIL’HIPS
UDI-DI code: 03701459811069
Basic UDI-DI: 37014598ABDCRY005STXN
Reference / catalog number: CRYOSTAB® STABIL’HIPS
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’immobilisation solidarise la partie proximale du fémur à la ceinture abdominale et permet une prise en charge optimale du complexe ilio-pelvien. 2 fermetures par auto-agrippants au niveau de la hanche et de la cuisse permettent un maintien et un positionnement optimal. L’ensemble CRYOSTAB® STABIL’HIPS est livrée avec 2 compresses de froid CryoStab® 14X28. L’ensemble CRYOSTAB® STABIL’HIPS PACK est composé la ceinture abdominale CRYOSTAB® STABIL’HIPS (livrée avec deux compresses de froid CryoStab® 14X28) et d’un CryoStab® RACK 14X28.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: TM - HAUTEUR DEVANT 25CM - TOUR DE BASSIN 90-104CM

EMDN nomenclature code(s)

Y060403ABDOMINAL MUSCLES SUPPORTS

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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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.