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Scuptra

by Q-Med AB Sweden EUDAMED

Ref 085557Model Sculptra

EMDN X0301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number73316890138V Basic UDI-DIDate27 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2268181TD02 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    3 Dec 2025
    Expires
    1 Dec 2030
  • 2268181CE02 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    3 Dec 2025
    Expires
    1 Aug 2030

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Sculptra
Model / Reference
Sculptra, 085557
Primary DI / UDI-DI
07331689855579
Basic UDI-DI
73316890138V
EMDN Code
X0301 Substances, 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, excluding those for tattooing – resorbable
Device Class
Class III
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
SE-MF-000008549

Other devices from Q-Med AB

See all devices from Q-Med AB →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 922b7e94-3a37-4467-9d3a-0634740c63d2 61 fields · synced 23 Oct 2026