Identity
- Trade Name
- FORTUNA EUDAMED
- Device Name
- FEMALE ELASTICATED KNEE SUPPORT EUDAMED
- Model / Reference
- FT14KS EUDAMEDFT1478 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05031720033004 EUDAMED
- Basic UDI-DI
- 5031720FT14KSDH EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fortuna by Fortuna Healthcare Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5031720FT14KSDH | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fortuna Healthcare Limited
- EUDAMED SRN
- UK-MF-000048072
- Authorised Representative
- Fortuna Healthcare (Ireland) Limited IE-AR-000044547
Sources (1)
- EUDAMED 0b35041d-9406-4206-807f-64f2c465ec49 61 fields · synced Jun 14, 2026