Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

SMARTLEG® Semi Transparent Classe… — Class I MDR

MD Atlas
Laboratoires INNOTHERA

EUDAMED last updated this device on Aug 27, 2025

SMARTLEG® Semi Transparent Classe II collant Lumineuse (Beige soutenu) Taille 2 Normal Pied fermé

3664540CVECL2ASQDT02YB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laboratoires INNOTHERA
UDI-DI code: 03664540000912
Reference / catalog number: 3664540000912

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

ACTYS ®ATH mixte Chaussette Taille 3 Normal Blanc Pied ouvert, Sachet3664540CVEATHASQDT04GXOn the market ACTYS 20 Homme Classe II Bas autofix Beige Taille 1 Long Pied fermé3664540CVECL2ASQDT02YBOn the market ACTYS 20 Homme Classe II Bas autofix Beige Taille 1 Normal Pied fermé3664540CVECL2ASQDT02YBOn the market ACTYS 20 Homme Classe II Bas autofix Beige Taille 1- Long Pied fermé3664540CVECL2ASQDT02YBOn the market ACTYS 20 Homme Classe II Bas autofix Beige Taille 1- Normal Pied fermé3664540CVECL2ASQDT02YBOn 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.

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.Réactions cutanées (éruptions cutanées, rougeurs,démangeaisons, irritations, ampoules au niveau de la bande autofix des bas.)

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® Semi Transparent Classe II collant Lumineuse (Beige soutenu) Taille 2 Normal Pied fermé
UDI-DI code: 03664540000912
Basic UDI-DI: 3664540CVECL2ASQDT02YB
Reference / catalog number: 3664540000912
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: —
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