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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 SET GENOU — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on May 27, 2024

CRYOSTAB SET GENOU

37014598TECCRY004STKZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03701459810758
Reference / catalog number: CRYOSTAB SET GENOU

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Manufacturer information

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

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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 SET GENOU
UDI-DI code: 03701459810758
Basic UDI-DI: 37014598TECCRY004STKZ
Reference / catalog number: CRYOSTAB SET GENOU
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: Les compresses CryoStab® ne brûlent pas et ne blessent pas les tissus cutanés. Les compresses CryoStab® sont non toxiques et ne sont pas destinées à un usage interne.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 14X14CM & 14X28CM

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.