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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

0392 — Class I MDR by SECURIMED

MD Atlas
SECURIMED

EUDAMED last updated this device on May 22, 2023

0392

37011402pochesdegelDV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SECURIMED
UDI-DI code: 03701140200882
Reference / catalog number: 0392

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Manufacturer information

Organization name: SECURIMED
SRN: FR-MF-000006782
Manufacturer status: Active

Related devices

HAEMOBAND37011402compressifsPHOn the market HAEMOBAND37011402compressifsPHOn the market REFRICONTACTB-03701140200844On the market REFRIDOLB-03701140200110On the market 497137011402compressifsPHOn the market

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.

CW010
Ne jamais utiliser la poche chaude ou froide en contact direct avec la peau. Utiliser des champs à usage unique pour isoler la poche de la peau.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03701140200882
Basic UDI-DI: 37011402pochesdegelDV
Reference / catalog number: 0392
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: Poche thermique destinée à soulager la douleur par cryothérapie ou thermothérapie.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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