RenoFoam SB
by T&L Co., Ltd. South Korea EUDAMED
Ref FB14EN25, FB14EN21, FB14EN22, FB14EN27, FB14EN24
EMDN M04040602
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08800048015040 | Date21 Nov 2025 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Adhesive Foam Dressing
- Model / Reference
- FB14EN25, FB14EN21, FB14EN22, FB14EN27, FB14EN24
- Primary DI / UDI-DI
- 08800048015040, 08800048015002, 08800048015019, 08800048015057, 08800048015033
- Basic UDI-DI
- B-08800048015040, B-08800048015002, B-08800048015019, B-08800048015057, B-08800048015033
- 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.
Properties & raw data
Show properties, registry sources and raw records
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 (5)
- EUDAMED 6c3d5bff-00db-4958-808c-2f06c88639cb
- EUDAMED 08800048015002|B-08800048015002
- EUDAMED 08800048015019|B-08800048015019
- EUDAMED 08800048015057|B-08800048015057
- EUDAMED 08800048015033|B-08800048015033