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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

ACTYS 35 Classe III Bas autofix… — Class I MDR

MD Atlas
Laboratoires INNOTHERA

EUDAMED last updated this device on Aug 22, 2025

ACTYS 35 Classe III Bas autofix Naturel Taille 1 Normal Pieds ouverts

3664540CVECL3ASQDT03YY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laboratoires INNOTHERA
UDI-DI code: 03664540017293
Reference / catalog number: 3664540017293

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Manufacturer information

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

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.Microangiopathie diabétique évoluée.

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 35 Classe III Bas autofix Naturel Taille 1 Normal Pieds ouverts
UDI-DI code: 03664540017293
Basic UDI-DI: 3664540CVECL3ASQDT03YY
Reference / catalog number: 3664540017293
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 produits de compression de classe 3 sont des produits de compression élastique, pièces de textiles enfilables sur les membres inférieurs. Ces produits appliquent en cheville une pression comprise entre 20,1 à 36 mmHg.
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

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