RenoFoam F
by T&L Co., Ltd. South Korea EUDAMED
Ref FF14EN23, FF14EN24, FO14EN04, FO14EN05
EMDN M04040601
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08800048019420 | Date20 Nov 2025 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Trade Name
- RenoFoam FRenoFoam
- Device Name
- Foam Dressing
- Model / Reference
- FF14EN23, FF14EN24, FO14EN04, FO14EN05
- Primary DI / UDI-DI
- 08800048019420, 08800048019482, 08800048018089, 08800048018218
- Basic UDI-DI
- B-08800048019420, B-08800048019482, B-08800048018089, B-08800048018218
- EMDN Code
- M04040601 Polyurethane dressings, non-combined
- 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 (4)
- EUDAMED cc90e3d4-0f96-48a7-a2a9-231d5c4005f9
- EUDAMED 08800048019482|B-08800048019482
- EUDAMED 08800048018089|B-08800048018089
- EUDAMED 08800048018218|B-08800048018218