Identity
- Trade Name
- Fortuna EUDAMED
- Device Name
- Reusable Hot Cold Pack EUDAMED
- Model / Reference
- FT15H EUDAMEDFT142 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05031720005551 EUDAMED
- Basic UDI-DI
- 5031720FT15HHQ EUDAMED
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT 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
Yes
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 | 5031720FT15HHQ | 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 c8935581-9530-49f6-bb5a-f3903827dc09 61 fields · synced Jun 19, 2026