Restylane Defyne

Organization name

Q-Med AB

SRN

SE-MF-000008549

Manufacturer status

Active

3 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.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 30 countries total.

Trade name

Restylane Defyne

UDI-DI code

D-012095LM

Basic UDI-DI

B-012095LM

Reference / catalog number

012095

Issuing entity

EUDAMED

Risk category

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Intended to augment the volume of facial tissues.

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.

• X0303SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE