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Ellansé M

by AQTIS Medical B.V.[EN] Netherlands EUDAMED

Ref 4000008

EMDN X0303

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50600330427180950212131J7 Basic UDI-DIDate20 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
4000008
Primary DI / UDI-DI
05060033044131
Basic UDI-DI
50600330427180950212131J7
EMDN Code
X0303 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, by a prefilled means for introduction, excluding those for tattooing – resorbable
Device Class
Class III
Medical Purpose
ELLANSÉ (a Poly-ɛ-caprolactone-based dermal filler) is a sterile, single use, injectable implant, resorbable device indicated for subdermal implantation in the face for the treatment and lasting correction of wrinkles and facial aging signs or conditions, or for implantation into the hands

Manufacturer details

EUDAMED SRN
NL-PR-000053083

Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED c72f1124-492c-4c00-9e63-2e5f0077e888 61 fields · synced 22 Oct 2026