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Organization name
UDI-DI code
Reference / catalog number

Actys Classe 1 Mi-bas Taille 4… — Class I MDR

MD Atlas
Laboratoires INNOTHERA

EUDAMED last updated this device on Aug 25, 2025

Actys Classe 1 Mi-bas Taille 4 Normal Beige Clair

3664540CVECL1ASQDT01XN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laboratoires INNOTHERA
UDI-DI code: 03664540050177
Reference / catalog number: 3664540050177

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Manufacturer information

Organization name: Laboratoires INNOTHERA
SRN: FR-MF-000004678
Manufacturer status: Active

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: Actys Classe 1 Mi-bas Taille 4 Normal Beige Clair
UDI-DI code: 03664540050177
Basic UDI-DI: 3664540CVECL1ASQDT01XN
Reference / catalog number: 3664540050177
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: ACTYS 10 est une gamme de produit de compression veineuse élastique, pièces de textiles enfilables sur les membres inférieurs, exerçant au niveau de la cheville une pression comprise entre 10 et 15 mmHg et qui décroit de la cheville vers le genou.Ces produits de compression veineuse élastique sont tricotés sur des métiers circulaires et proposés sous différents formats : Chaussettes, bas autofix
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

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.

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