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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

CML CRYOSTAB — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Jan 10, 2025

CML CRYOSTAB

37014598LOMCRY001STU2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03701459809769
Reference / catalog number: CML CRYOSTAB

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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

1 warning recorded — scroll inside the panel to see all entries.

CW018
EUDAMED did not publish a description for this code.

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: CML CRYOSTAB
UDI-DI code: 03701459809769
Basic UDI-DI: 37014598LOMCRY001STU2
Reference / catalog number: CML CRYOSTAB
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 de maintien lombaire « CML CRYOSTAB » se compose : • d’un tissu élastique ajouré très résistant, • au niveau dorsal : de 4 baleines, d’un dos en tissu velours pour plus de confort & deux emplacements pour compresse de froid en tissu coton, • de baleines dorsales modelables en fonction de la morphologie du patient, • d’une fermeture ergonomique grâce aux passes doigts intégrés et aux bandes auto-agrippantes, • d’un coussin cicatriciel à apposer sur une cicatrice protégée, • d’une protection en non-tissé se positionnant sur le dos, en contact avec le patient. L’ensemble CML CRYOSTAB est livré avec deux compresses CRYOSTAB® 14X28.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: T5 - Hauteur 26cm - Tour de taille 110-120cm

EMDN nomenclature code(s)

Y060309THORACOLUMBOSACRAL SPINE 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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Software identification