Identity
- Trade Name
- I-ON CXL EUDAMED
- Device Name
- I-ON CXL EUDAMED
- Model / Reference
- TF45-01-1Z EUDAMEDSOOFT101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SOOFT101YW EUDAMED
- Basic UDI-DI
- B-SOOFT101YW EUDAMED
- EMDN Code
- Z120604 IONTOPHORESIS EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
I-On Cxl by Fidia Farmaceutici S.p.A. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-SOOFT101YW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (1)
- EUDAMED e29fd8b9-a6e9-4a68-8778-8a0b845cc6c0 61 fields · synced Jul 20, 2026