Identity
- Trade Name
- IGENAL N EUDAMED
- Device Name
- IGENAL N EUDAMED
- Model / Reference
- FT10 EUDAMEDFM1211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FM12115M EUDAMED
- Basic UDI-DI
- B-FM12115M EUDAMED
- EMDN Code
- D0901 AMMONIUM SALTS FOR THE DISINFECTION OF MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class IIb 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
Igenal N by Mondial Srl — 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-FM12115M | Class IIb | Active |
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Manufacturer
- Manufacturer
- Mondial Srl
- EUDAMED SRN
- IT-MF-000022978
Sources (1)
- EUDAMED 1b2a0ad0-6e46-420e-acb3-6a8698c7eba9 61 fields · synced Jun 19, 2026