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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® LOMBAIRE — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Jan 11, 2024

CRYOSTAB® LOMBAIRE

376003544ABDCRY003STT9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03760035448976
Reference / catalog number: CRYOSTAB® LOMBAIRE

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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® LOMBAIRE
UDI-DI code: 03760035448976
Basic UDI-DI: 376003544ABDCRY003STT9
Reference / catalog number: CRYOSTAB® LOMBAIRE
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 ceinture abdominale est composée d’un tissu ajouré très souple favorisant la cicatrisation par pressothérapie. Elle est composée d’une mousse intérieure épaisse formant un coussin cicatriciel. L’ensemble CryoStab® LOMBAIRE est composé d’une ceinture abdominale et de deux compresses CryoStab® 14X28. L’ensemble CryoStab® LOMBAIRE Pack est composé d’une ceinture abdominale (livrée avec deux compresses CryoStab® 14X28) et d’un CryoStab® RACK 14X28. Composition : Nylon, coton, polyamide, polyester, fil de gomme, acier, élasthanne. Absence de latex, de phtalates, de de produit d’origine animale ou biologique.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: TM - H31 - TOUR DE TAILLE : 95-105CM

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

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