Identity
- Trade Name
- OPTIVE UD EUDAMED
- Device Name
- Dry Eye Comfort Solutions and Ointments EUDAMED
- Model / Reference
- 93416EW EUDAMED93416IT EUDAMED93715EW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10840228300547 EUDAMED10840228300561 EUDAMED10840228300769 EUDAMED
- Basic UDI-DI
- 0840228300034F EUDAMED
- Unit of Use DI
- 20840228300544 EUDAMED20840228300568 EUDAMED20840228300766 EUDAMED
- EMDN Code
- Q02030206,Q02030299,Q0299 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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 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 3e28837b-4323-473a-8aa6-c0ba6289050a 61 fields · synced Jul 25, 2026
- EUDAMED 63d13afc-3c48-4048-a699-b37f067a9974 61 fields · synced May 17, 2026
- EUDAMED da480739-c5dd-46d5-a6ee-1cd58e0f440d 61 fields · synced May 17, 2026