Organization name

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

SRN

IT-MF-000009981

Manufacturer status

Active

D-PlenhyageXLThin40345DA

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

13 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 the product: • For peri-orbital injections or intravascular/intralymphatic injections. • In patients with circulatory disorders, active dermatitis, epilepsy, diabetes, active herpes or other infections, autoimmune diseases, severe allergies, active inflammation, or hypersensitivity to the product components. • During pregnancy, breastfeeding, or in patients under 18 years of age.

  OTHER

• WARNINGS • For subcutaneous or intradermal use only; never inject intravascularly. • Aspirate before each injection to avoid accidental vascular injection. • Single-use sterile device; do not re-sterilize or reuse. • Use immediately after opening. • Do not mix with other injectable products. • Do not inject into inflamed, infected, or damaged skin. • Patients taking anticoagulants or antiplatelet drugs have an increased risk of bruising or bleeding and should consult their physician before treatment. • Keep out of reach of children.

  OTHER

• PRECAUTIONS • Use only according to the instructions. • Do not use if the syringe, blister, or needles are damaged, or if the gel appears cloudy or contains particles. • Use sterile needles only. • Ensure proper skin disinfection before treatment. • Advise patients to avoid makeup for 24 hours and avoid direct sunlight, UV exposure, and extreme temperatures until recovery. • Delay laser, chemical peel, or dermabrasion procedures until complete healing. • Dispose of syringes and needles according to medical regulations.

  OTHER

• ADVERSE REACTIONS Possible transient injection-site reactions include: • Swelling • Bruising • Mild edema Patients should promptly report any severe or unexpected adverse reaction to their physician.

  OTHER

• STERILIZATION • Syringe contents are manufactured under aseptic conditions. • Needles are sterilized by irradiation.

  OTHER

• STORAGE CONDITIONS • Store in a dry place, protected from light. • Storage temperature: 5°C–25°C. • Do not use after the expiration date.

  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-PlenhyageXLThin40345DA

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-PlenhyageXLThin40345DA

Reference / catalog number

40345

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

• 2 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.