Identity
- Trade Name
- FORTUNA EUDAMED
- Device Name
- NEOPRENE ELBOW SUPPORT EUDAMED
- Model / Reference
- EX900E EUDAMEDFT095 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05031720012467 EUDAMED
- Basic UDI-DI
- 5031720EX900ECA EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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 | 5031720EX900ECA | Class I | Active |
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Manufacturer
- Manufacturer
- Fortuna Healthcare Limited
- EUDAMED SRN
- UK-MF-000048072
- Authorised Representative
- Fortuna Healthcare (Ireland) Limited IE-AR-000044547
Sources (1)
- EUDAMED c0220ec5-b9b5-4064-bd66-c8ffe5af9567 61 fields · synced Jun 18, 2026