Identity
- Trade Name
- TRIUM EUDAMED
- Device Name
- TRIUM EUDAMED
- Model / Reference
- OP21-01 EUDAMED10001215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033661809509 EUDAMED
- Basic UDI-DI
- 80336618004210100000000QS EUDAMED
- EMDN Code
- Q02030206 EYE LUBRICANT SOLUTIONS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Romania 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 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 | 80336618004210100000000QS | Class IIb | Active |
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Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (1)
- EUDAMED a0bd3354-d8ba-475a-bed0-5a2a7c91ce66 61 fields · synced Jun 19, 2026