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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

Smartleg BB Transparent Classe 2… — Class I MDR

MD Atlas
Laboratoires INNOTHERA

EUDAMED last updated this device on Aug 28, 2025

Smartleg BB Transparent Classe 2 Collant Taille 1+ Long Radieuse Soft Pied Ouvert

3664540CVECL2ASQDT02YB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laboratoires INNOTHERA
UDI-DI code: 03664540050412
Reference / catalog number: 3664540050412

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Manufacturer information

Organization name: Laboratoires INNOTHERA
SRN: FR-MF-000004678
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.

CW999
Intolérance / Réaction allergique au produit.Artériopathie oblitérante des membres inférieurs (AOMI) avec index de pression systolique (IPS) < 0,6.Phlegmatia coerulea dolens (phlébite bleue douloureuse avec compression artérielle).Thrombose septique.

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: Smartleg BB Transparent Classe 2 Collant Taille 1+ Long Radieuse Soft Pied Ouvert
UDI-DI code: 03664540050412
Basic UDI-DI: 3664540CVECL2ASQDT02YB
Reference / catalog number: 3664540050412
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: Le dispositif médical est un produit de compression veineuse élastique, pièces de textiles enfilables sur les membres inférieurs exerçant au niveau de la cheville une pression comprise entre 15,1 et 20 mm Hg et qui décroit de la cheville vers le genou
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M030405COMPRESSION STOCKINGS

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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