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Nexsphere™

by Nextbiomedical Co., Ltd. South Korea EUDAMED

Ref UIGB300

EMDN C010402020303

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800038404519 Basic UDI-DIDate7 Jul 2022RegisteredStatusActive

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 22 Oct 2026

Device Name
Embolic gelatin microspheres
Model / Reference
UIGB300
Primary DI / UDI-DI
08800038404519
Basic UDI-DI
B-08800038404519
EMDN Code
C010402020303 Embolisation particles and microspheres
Device Class
Class III
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
KR-MF-000004808
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Nextbiomedical Co., Ltd.

See all devices from Nextbiomedical Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • Animal Tissues
Other properties (8)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 93943635-0378-4f0c-b506-27dd8242c1b2 61 fields · synced 22 Oct 2026