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Optive Plus
EUDAMEDClass IIb (EU MDR)
Ref 94306GBRef 94307TBRef 94307UCRef 94307ITRef 94307EERef 94306ELRef 94306TCRef 94307XZRef 94307FCRef 94307RORef 94306SQRef 94307CQ
Identity
- Trade Name
- OPTIVE PLUS EUDAMED
- Device Name
- Dry Eye Comfort Solutions and Ointments EUDAMED
- Model / Reference
- 94306GB EUDAMED94307TB EUDAMED94307UC EUDAMED94307IT EUDAMED94307EE EUDAMED94306EL EUDAMED94306TC EUDAMED94307XZ EUDAMED94307FC EUDAMED94307RO EUDAMED94306SQ EUDAMED94307CQ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10840228300714 EUDAMED10840228301506 EUDAMED10840228301490 EUDAMED10840228301537 EUDAMED10840228302244 EUDAMED10840228300721 EUDAMED10840228300684 EUDAMED10840228301483 EUDAMED10840228301568 EUDAMED10840228301513 EUDAMED10840228300707 EUDAMED10840228300653 EUDAMED
- Basic UDI-DI
- 0840228300034F EUDAMED
- Direct Marketing DI
- 10840228300714 EUDAMED10840228301506 EUDAMED10840228301490 EUDAMED10840228301537 EUDAMED10840228302244 EUDAMED10840228300721 EUDAMED10840228300684 EUDAMED10840228301483 EUDAMED10840228301568 EUDAMED10840228301513 EUDAMED10840228300707 EUDAMED10840228300653 EUDAMED
- EMDN Code
- Q02030206,Q02030299,Q0299 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMEDBulgaria EUDAMEDItaly EUDAMEDLatvia EUDAMEDFinland EUDAMEDGermany EUDAMEDSlovenia EUDAMEDLiechtenstein EUDAMEDSlovakia EUDAMEDBelgium EUDAMEDCroatia 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 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 (12)
- EUDAMED c67b155e-2bcc-46ba-817d-b9236f355584 61 fields · synced Aug 2, 2026
- EUDAMED b08592fe-99f6-4f26-a1e6-b00b646d406b 61 fields · synced May 17, 2026
- EUDAMED 37e8a83b-a594-4a26-9c3d-0156194701d0 61 fields · synced May 17, 2026
- EUDAMED 06982238-e615-43ae-bdc3-16c73e19678d 61 fields · synced May 17, 2026
- EUDAMED 4c734166-c40c-484c-bdc7-5f043d61a7ae 61 fields · synced May 17, 2026
- EUDAMED e94940eb-5953-4b09-ae30-12367678bb85 61 fields · synced May 17, 2026
- EUDAMED aa4a8004-2de3-43ec-88eb-b42875b715b5 61 fields · synced May 18, 2026
- EUDAMED e9b62b8a-7d6f-4ddc-8bca-885e76d6af6d 61 fields · synced May 18, 2026
- EUDAMED 34c9ac9f-77fa-47f0-aedc-bf111c298610 61 fields · synced May 18, 2026
- EUDAMED 1255f201-9de6-4c58-ab57-4d5b6398364f 61 fields · synced May 19, 2026
- EUDAMED 5a659cbf-b0d1-4b78-a8ea-2e9dd8d5fd2f 61 fields · synced May 19, 2026
- EUDAMED 919e42f3-17fa-4f1f-8ccf-92e9d854300f 61 fields · synced May 19, 2026