Organization name

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

SRN

IT-MF-000009981

Manufacturer status

Active

D-Jalucomplex75478E

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.

14 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use
• Do not re-use
• Do not sterilise
• Do not use if package is damaged
• Do not use past indicated date
• If any symptoms are troublesome or last more than a few days or if you notice any side effects not mentioned, please inform your doctor or pharmacist
• P102 – Keep out of reach of children.
• CONTRAINDICATIONS Do not use: • For injections in the periorbital area (eyelids or under-eye bags). • For intravascular injections. • For breast augmentation or injections into bone, tendons, ligaments, or muscles. • In patients with a history of hypertrophic or keloid scarring, pigmentation disorders, autoimmune diseases, severe allergies, active inflammatory conditions, coagulation disorders, or known hypersensitivity to hyaluronic acid. • During pregnancy, breastfeeding, or in individuals under 18 years of age.

  OTHER

• WARNING • For subcutaneous or intradermal use only; never inject into blood vessels. • Accidental intravascular injection may cause serious complications such as vascular occlusion, necrosis, or embolism. • Single-use, sterile product intended for one patient only; do not reuse or re-sterilize. • Use immediately after opening and discard after use. • Do not use after the expiration date. • Do not mix with or administer alongside other injectable products. • Do not inject into infected or inflamed skin. • Patients taking anticoagulants or blood-thinning medications may have increased bleeding or bruising and should follow medical advice before treatment. • Keep out of the reach of children.

  OTHER

• PRECAUTIONS • Do not use if the gel is cloudy, contains particles, or if the syringe, blister, or needles are damaged. • Use only sterile needles and follow strict aseptic technique. • Thoroughly clean and disinfect the skin before treatment. • Do not inject into infected or inflamed areas. • Avoid combining with other aesthetic injectable treatments in the same area. • Patients should avoid makeup for 24 hours after treatment. • Avoid direct sunlight, UV exposure, and extreme cold until redness and swelling have resolved. • Delay treatment if laser therapy, chemical peeling, or dermabrasion has recently been performed until the skin has completely healed. • Dispose of syringes and needles according to approved medical procedures.

  OTHER

• ADVERSE REACTIONS Possible temporary reactions include: • Redness, swelling, pain, tenderness, rash, or discoloration at the injection site. • Small edema resolving within a few days. • Rare cases of bruising or bleeding. • Temporary acne-like papules. • Allergic reactions to hyaluronic acid. • Nodules or tissue hardening. • Very rare cases of granulomas, severe inflammatory reactions, petechiae, necrosis, or urticaria. Patients should immediately report any severe or unexpected adverse reaction to their physician.

  OTHER

• STORAGE CONDITIONS • Store in a dry place, protected from light. • Store between 5°C and 25°C. • Do not use after the expiration date. • Handle with care, as the product is fragile.

  OTHER

• INCOMPATIBILITY Avoid contact with quaternary ammonium salts (such as benzalkonium chloride) and with medical materials treated with these substances, as they are incompatible with hyaluronic acid.

  OTHER

• STERILISATION • Syringe contents are sterilized by steam. • Needles are sterilized by irradiation.

  OTHER

Primary placement in Italy; available across 27 countries total.

Trade name

not provided

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

D-Jalucomplex75478E

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-Jalucomplex75478E

Reference / catalog number

7547

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

EUDAMED

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 1.5 MU48

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

• Class III medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.