ITF008/e

Organization name

Italfarmacia srl

SRN

IT-MF-000013116

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW011

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

  EUDAMED did not publish a description for this code.
• CW001

  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.
• CW277

  EUDAMED did not publish a description for this code.

Primary placement in Sweden; available across 1 country total.

Trade name

not provided

UDI-DI code

08055715336250

Basic UDI-DI

805571533ITF00578abdYB

Reference / catalog number

ITF008/e

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

2

Additional product description

MOLDERM IS A MONOPHASIC, STERILE, NON-PYROGENIC AND INJECTABLE HYDROGEL FOR THE CORRECTION OF SOFT TISSUE DEFICITS. THE PRODUCT DEGRADES SLOWLY AFTER IMPLANTATION. THE HYDROGEL IS BASED ON HIGHLY PURIFIED CROSS-LINKED SODIUM HYALURONATE OF NON-ANIMAL ORIGIN, PRODUCED BY BACTERIAL FERMENTATION. COMPOSITION MOLDERM is available in three different concentrations of hyaluronic acid: 22 mg/ml , 24 mg/ml and 26 mg/ml. MOLDERM VOLUME in 1 ml syringe, contains 26 mg/ml of cross-linked sodium hyaluronate, in sterile buffered water, with the addition of glycine and proline amino acids. Package contents • 2 sealed blister packs, each containing 1 sterile single-use pre-filled syringe with luer-lock connection and 27G-13 mm or 25G-16 mm sterile needles. • Patient information leaflet. • Adhesive labels for traceability. • Implant cards - Instructions for implant card use and correct filling in. Indications MOLDERM in the three different concentrations of hyaluronic acid is indicated for the restoration of facial volumes, correction of facial asymmetry, lipoatrophy and scars.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES