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RenoFoam SB

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

Ref FB14EN29

EMDN M04040602

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800048015064 Basic UDI-DIDate21 Nov 2025RegisteredStatusActive

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 25 Oct 2026

Device Name
Adhesive Foam Dressing
Model / Reference
FB14EN29
Primary DI / UDI-DI
08800048015064
Basic UDI-DI
B-08800048015064
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 0e9d0fa9-9bd3-43a1-bd0f-1efb2efd91e7 61 fields · synced 25 Oct 2026