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RenoFoam SB

by T&L Co., Ltd. South Korea EUDAMED

Ref FB14EN23 EMDN M04040602

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800048015026 Basic UDI-DIDate21 Nov 2025RegisteredStatusActive

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  • Withdrawn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
Adhesive Foam Dressing
Model / Reference
FB14EN23
Primary DI / UDI-DI
08800048015026
Basic UDI-DI
B-08800048015026
EMDN Code
M04040602 Polyurethane dressings, combined with other substances
Device Class
Class IIb
Market of Registration
Croatia

Manufacturer details

EUDAMED SRN
KR-MF-000016624
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from T&L Co., Ltd.

See all devices from T&L Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • 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 7294fcc8-ffe2-4e65-b0d1-af6ea99a41e2 61 fields · synced 25 Oct 2026