Identity
- Trade Name
- OPTAVA FUSION EUDAMED
- Device Name
- Dry Eye Comfort Solutions and Ointments EUDAMED
- Model / Reference
- 94606EM EUDAMED94607EK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10840228301353 EUDAMED10840228301247 EUDAMED
- Basic UDI-DI
- 0840228300034F EUDAMED
- Direct Marketing DI
- 10840228301353 EUDAMED10840228301247 EUDAMED
- EMDN Code
- Q02030206,Q02030299,Q0299 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optava Fusion by Allergan Sales, LLC — 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 | 0840228300034F | Class IIb | Active |
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Manufacturer
- Manufacturer
- Allergan Sales, LLC
- EUDAMED SRN
- US-MF-000001517
- Authorised Representative
- Allergan Pharmaceuticals International Limited IE-AR-000000650
Sources (2)
- EUDAMED 1a6169e5-0ef0-4595-b793-7710b45e3e13 61 fields · synced Aug 2, 2026
- EUDAMED 3fea18c6-dffc-4edc-8235-128f0964be29 61 fields · synced May 17, 2026