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Nuvene Shine

by BioPlus Co., Ltd. South Korea EUDAMED

Ref BPBN-31 EMDN X0303

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800259430663 Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Sterile Absorbable Hyaluronic Acid Dermal Filler
Model / Reference
BPBN-31
Primary DI / UDI-DI
08800259430663
Basic UDI-DI
B-08800259430663
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
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000008618
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from BioPlus Co., Ltd.

See all devices from BioPlus Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08800259430663|B-08800259430663 61 fields · synced 25 Oct 2026