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Ultracol

by ULTRA V Co., Ltd. South Korea EUDAMED

Ref U00050Model ULTRACOL50

EMDN P010199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800070100134 Basic UDI-DIDate22 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
ULTRACOL50, U00050
Primary DI / UDI-DI
08800070100134
Basic UDI-DI
B-08800070100134
EMDN Code
P010199 Facial prostheses - other
Device Class
Class III
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000022614
Authorised representative
Intermundien - Lemon Europe GmbH DE-AR-000011931

Related devices

Category: Silicone-block tissue reconstructive material

Other devices from ULTRA V 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 935c99dd-31b4-408d-9df8-b3ae236b1b38 61 fields · synced 24 Oct 2026