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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

CALECHE COMPACT — Class I MDR by France Reval

MD Atlas
France Reval

EUDAMED last updated this device on Mar 12, 2026

CALECHE COMPACT

3666401BA005HT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: France Reval
UDI-DI code: 36664010022404
Reference / catalog number: 4600.01

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Manufacturer information

Organization name: France Reval
SRN: FR-MF-000011523
Manufacturer status: Active

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Critical warnings

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

CW999
Comprendre le manuel d'utilisation avant utilisation. Ne jamais laisser un patient sans surveillance. Ne jamais dépasser la capacité de charge maximale d'utilisation. Ne pas utiliser d'objet électrique dans ou à proximité du bain. Toujours vérifier la température de l'eau avant le bain ou la douche du patient. Vérifier le bon verrouillage de la porte avant le remplissage.

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Belgium	Mar 12, 2010	Still on market

Device identification

Trade name: CALECHE COMPACT
UDI-DI code: 36664010022404
Basic UDI-DI: 3666401BA005HT
Reference / catalog number: 4600.01
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 baignoire CALECHE COMPACT à hauteur ergonomique et porte latérale est destinée aux bains et à la douche des patients. Elle est conçue avec un seuil bas permettant un accès facilité pour toutes les personnes déambulantes et autonomes.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y093399WASHING, BATHING AND SHOWERING DEVICES - OTHER

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.