Iceross Seal-In® X5 TF
by Össur Iceland ehf. EUDAMED
Active
Ref I-TF67328Model BU00001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5690967BU00001MT | Date26 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- BU00001, I-TF67328
- Primary DI / UDI-DI
- 05690967513207
- Basic UDI-DI
- 5690967BU00001MT
- EMDN Code
- Y062415 Transfemoral prostheses (for amputation above knee)
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- IS-MF-000000173
Other devices from Össur Iceland ehf.
Properties
Show properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No