Identity
- Trade Name
- OPTIVE PLUS UD EUDAMED
- Device Name
- Dry Eye Comfort Solutions and Ointments EUDAMED
- Model / Reference
- 94542FC EUDAMED94542EW EUDAMED94542IT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10840228301407 EUDAMED10840228301414 EUDAMED10840228301384 EUDAMED
- Basic UDI-DI
- 0840228300034F EUDAMED
- Unit of Use DI
- 20840228301404 EUDAMED20840228301411 EUDAMED20840228301381 EUDAMED
- EMDN Code
- Q02030206,Q02030299,Q0299 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Liechtenstein EUDAMEDGermany EUDAMEDItaly 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
Optive Plus Ud 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 (3)
- EUDAMED 4bff6fe2-7ba7-41b3-a666-1120ce88ff53 61 fields · synced Aug 4, 2026
- EUDAMED b0c30748-8aa2-4fc2-a7fb-73aaa8a622f6 61 fields · synced May 17, 2026
- EUDAMED 07a7533b-c746-43fa-bf03-b2efa7274023 61 fields · synced May 18, 2026