Identity
- Trade Name
- TRIUM MONODOSE EUDAMED
- Device Name
- TRIUM MONODOSE EUDAMED
- Model / Reference
- OP21-02 EUDAMED13001267 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055267241637 EUDAMED
- Basic UDI-DI
- 80336618004210200000000RH EUDAMED
- EMDN Code
- Q02030206 EYE LUBRICANT SOLUTIONS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Trium Monodose by Fidia Farmaceutici S.p.A. — Class IIb — 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 | 80336618004210200000000RH | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (1)
- EUDAMED 47f13418-43ed-4dce-9f4f-7e4ee41157f8 61 fields · synced Jun 19, 2026