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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® GO PACK — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Jan 11, 2024

CRYOSTAB® GO PACK

376003544EPACRY001ST9F

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03760035445968
Reference / catalog number: CRYOSTAB® GO 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 la 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® GO PACK
UDI-DI code: 03760035445968
Basic UDI-DI: 376003544EPACRY001ST9F
Reference / catalog number: CRYOSTAB® GO 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: Création originale du Docteur BERREHAIL®. Le GO est un gilet d’épaule composée d’une robe en complexe ajouré ép. 4mm maille/maille. Dispositif en 1 partie qui s’adapte aux différentes phases du traitement du patient. Possibilité de libérer l’avant-bras tout en garantissant une immobilisation optimale de l’épaule. Pose facile en 4 étapes. L’utilisation de ce produit est strictement personnelle. L’ensemble CryoStab® GO est composé du gilet orthopédique GO & de deux compresses CryoStab® 14X28. L’ensemble CryoStab® GO Pack est composé d’un CryoStab® GO (livré avec deux compresses CryoStab® 14X28) et d’un CryoStab® RACK 14X28.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: T4/L

EMDN nomenclature code(s)

M030504IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES

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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