Nom de l'organisation

I.R.A. Istituto Ricerche Applicate S.p.A.

SRN

IT-MF-000009981

Statut du fabricant

Actif

D-Evanthia20-401676Z

La génération de DataMatrix prend en charge les IUD émis par GS1. La prise en charge HIBCC / ICCBBA / IFA arrive bientôt.

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• Consulter la notice d’utilisation
• NEGATIVE REACTIONS • Patients should be informed of potential immediate or delayed adverse effects. • Common reactions include pain, itching, pigmentation or tissue density changes, and oedema, usually resolving within one week. • Other possible reactions include: - inflammatory reactions and tenderness lasting up to one week; - bleeding or haematoma (rare); - follicular papules/pustules appearing up to 4 weeks after treatment; - allergic reactions to hyaluronic acid; - hardening or nodules at the injection site; - very rare cases of granulomas, wheals, necrosis, rash, or severe inflammatory reactions, which may occur 2–4 weeks after treatment. • Any adverse reaction should be reported to the physician, who should provide appropriate treatment and notify the manufacturer.

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• INCOMPATIBILITY • Hyaluronic acid is incompatible with quaternary ammonium salts (e.g., benzalkonium chloride). • Avoid contact with these substances or medical devices containing them.

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• En cas de symptômes gênants ou d’une durée de plusieurs jours ou si vous constatez des effets indésirables non mentionnés, veuillez en informer votre médecin ou votre pharmacien.
• STORAGE CONDITIONS • Check the expiry date on the syringe, blister, or package before use. • Store in a dry place, protected from light, at 5–25°C. • Handle with care; fragile product.

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• Ne pas réutiliser
• Ne pas stériliser
• Ne pas utiliser si l’emballage est endommagé
• Ne pas utiliser après la date indiquée
• P102 - Tenir hors de portée des enfants.
• To be implanted only in an appropriate medical setting by suitably trained, qualified or accredited doctors in accordance with national legislation.

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• STERILISATION • Syringe contents are steam sterilised. • 30G 1/2" and 27G 1/2" needles are irradiation sterilised.

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• CONTRAINDICATIONS The device must not be used: - for injections in the periorbital area (eyelids, dark circles); - for injections into blood vessels or nerves; - for breast tissue augmentation or for implantation in bones, tendons, ligaments or muscles. The device must not be administered to patients with: - known tendency to develop hypertrophic or keloid scars or pigmentation disorders; - previous autoimmune diseases in progress or undergoing immunotherapy; - multiple severe allergies or ongoing inflammatory processes; - coagulation disorders; - known hypersensitivity to hyaluronic acid. The device must not be used on pregnant or breastfeeding women, or on persons under the age of eighteen.

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• WARNINGS The device is intended to be injected subcutaneously or intradermally only and must not be injected intravascularly. The device is supplied as a sterile, single-use product and must not be resterilised. Do not reuse. It is not recommended to use needles other than those contained in the package or recommended in the instructions for use herein, in the "How to use" section. The Manufacturer cannot be held responsible for the safety and performance of the device if used with an inappropriate needle or in case of reuse. If supplied, do not use the supplied needles if the package is not perfectly intact or if they are bent and/or deformed. Do not use the device if the syringe or blister appears to be damaged. Do not use after the expiry date indicated on the packaging. Do not use the device in combination with other injectable products or mix it with other preparations before use. Do not use the product if the contents of the syringe appear cloudy or contain particles; in this case, promptly inform I.R.A. Istituto Ricerche Applicate at the address shown below. Do not use the device if skin shows signs of redness, swelling or pigmentation changes; do not use the device in the event of inflammation, infection or fever. Do not use in patients with ongoing infections or inflammatory conditions at or near the injection site. Do not use in patients taking anticoagulant medications (such as aspirin) as they may cause bruising or severe bleeding at the injection site. Do not use the device right after a laser treatment, chemical peel or dermabrasion, as this may cause an inflammatory reaction. Do not perform a laser treatment, chemical peel or dermabrasion after a treatment with the device until the side effects of the treatment have completely stopped.

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• PRECAUTIONS Only use the device in accordance with these instructions for use. The device was packaged to be used on one patient only. Use the device immediately after opening the blister pack and discard the syringe immediately after use, even if the entire contents have not been used. The injection volume depends on the level of correction required and is at the doctor’s discretion. The notches on the syringe label only serve to guide the user. As a precautionary measure, a maximum dose per year of 24 mL is recommended. There is no evidence to support the use of doses greater than 24 mL of the device per 70 kg of body mass per year. It is recommended that physicians perform a test injection and observe the patient for at least 2 minutes to ensure that no acute allergic reaction occurs before proceeding with the main injection. Follow all normal precautions for use associated with intradermal injection procedures. The injection is linked to an inherent risk of infection, therefore the device is intended for use in a healthcare setting. Skin must be thoroughly cleansed and disinfected before treatment. The technique and depth of injection vary depending on the area to be treated. Never apply excessive pressure to the syringe. Delicate massage of the treated area promotes a homogeneous distribution of the product. Advise the patient to refrain from wearing make-up for 24 hours after the injection and inform them that, during the period of remission, or until swelling or redness has completely subsided, they should avoid exposing the treated area to direct sunlight, UV lamps or cold.

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• PRECAUTIONS In consultation with their doctor, patients on anticoagulant treatment should suspend the use of this medication for at least 14 days before receiving the device injections. No clinical data is available to support the use of the device before or after skin treatments with other dermal or intradermal products, until the possible side effects of the treatment have completely stopped. It is suggested to follow the precautions prescribed by guidelines and common clinical practice. After use, syringes and needles can pose a potential biohazard. Handle with care and dispose of in compliance with the disposal rules established by the local authority. When performing the injection procedure, there is a potential risk that the material may be inadvertently injected into the blood vessels. In rare cases this could cause vascular occlusion, abscess, necrosis or embolic phenomena, as amply described in literature. To check that the needle is not inside a blood vessel during normal use of the medical device, lightly aspirate with the syringe before the injection.

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• PRECAUTIONS Keep the product out of sight and reach of children. For more information on the safety and clinical performance of this medical device, a Summary of Safety and Clinical Performance (SSPC) is available on request, prepared pursuant to Article 32 of Regulation (EU) 2017/745. The summary is publicly available on the European database EUDAMED (https://ec.europa.eu/tools/eudamed/eudamed), using the UDI-DI identifier of the device or the trade name. The list of harmonized standards and common specifications applied to the device is available in the SSCP. Very important: before starting treatment, the doctor should inform the patient about the composition, characteristics, precautions for use, warnings, contraindications and potential adverse reactions associated with this device. In addition, the doctor should first check the patient's medical history, assess any previous immunological or allergic reactions they may have and ascertain whether the device is compatible for use. Finally, the doctor must evaluate the skin areas involved in the treatment, to ascertain the suitability of the patient for the filler procedure and the actual usefulness of the treatment. The device can only be administered by medical personnel qualified for the injection technique.

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Marché principal en Italie ; disponible dans 20 pays au total.

Dénomination commerciale

non renseigné

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

D-Evanthia20-401676Z

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

B-Evanthia20-401676Z

Numéro de référence/catalogue

40167

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

EUDAMED

Catégorie de risque

Classes de risque MDR

Les classes de risque du MDR classent les dispositifs médicaux du risque le plus faible (classe I) au plus élevé (classe III), ce qui détermine le niveau de contrôle réglementaire.

Classe III

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 1 MU48

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

• Dispositifs médicaux de Classe III dans EUDAMED

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.