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Fora-B

by Seawon Meditech Co., Ltd. South Korea EUDAMED

Ref COB20S-2

EMDN N02010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809272563259 Basic UDI-DIDate11 Apr 2023RegisteredStatusActive

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

Device Name
Fora-B & Fora-B Tf
Model / Reference
COB20S-2
Primary DI / UDI-DI
08809272563259
Basic UDI-DI
B-08809272563259
EMDN Code
N02010102 Peridural / epidural catheters for continuous analgesia and kits
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000007442
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Seawon Meditech Co., Ltd.

See all devices from Seawon Meditech Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 1dc27669-4ae0-45bd-97dc-8bda63742858 61 fields · synced 24 Oct 2026