-

Trade name

not provided

UDI-DI code

08428991000281

Basic UDI-DI

B-08428991000281

Reference / catalog number

-

Issuing entity

GS1

Risk category

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 MU48

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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

• CW001

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW135

  EUDAMED did not publish a description for this code.
• CW276

  Do not administer Harmonie in immediate association with laser or pulsed light treatments
• CW161

  Harmonie should not be administered to pregnant or breastfeeding women.
• CW010

  EUDAMED did not publish a description for this code.
• CW999

  Do not administer Harmonie to patients with known hypersensitivity (allergy) to hyaluronic acid and / or other components of the product. Do not administer Harmonie to patients with acute or chronic dermatological disorders or an inflammatory and / or infectious type skin problem. Do not administer Harmonie to patients with coagulation defects and / or who are treated with anticoagulant medication. Harmonie should not be injected into blood vessels or eyelids; intravascular injection may produce embolization, occlusion of the vessels, ischemia, blindness or infarction. Harmonie should be administered exclusively by intradermal injection following a strict aseptic procedure. Harmonie should be administered with sterile Luer-lock needles (as supplied with the product). It is recommended that the patient do not wear makeup for 12 hours after the injection and avoid prolonged exposure to the sun, to ultraviolet rays, at temperatures below 0°C, as well as the sauna or Turkish bath during two weeks following the injection.

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