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Optive Fusion Ud
EUDAMEDClass IIb (EU MDR)
Ref 95537TCRef 94515MARef 98217CMRef 95537QSRef 95537SGRef 95537SCRef 95537AQRef 94515FP
Identity
- Trade Name
- OPTIVE FUSION UD EUDAMED
- Device Name
- Dry Eye Comfort Solutions and Ointments EUDAMED
- Model / Reference
- 95537TC EUDAMED94515MA EUDAMED98217CM EUDAMED95537QS EUDAMED95537SG EUDAMED95537SC EUDAMED95537AQ EUDAMED94515FP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10840228302275 EUDAMED10840228301438 EUDAMED10840228301681 EUDAMED10840228302305 EUDAMED10840228302282 EUDAMED10840228302299 EUDAMED10840228302312 EUDAMED10840228301452 EUDAMED
- Basic UDI-DI
- 0840228300034F EUDAMED
- Unit of Use DI
- 20840228302272 EUDAMED20840228301435 EUDAMED20840228301688 EUDAMED20840228302302 EUDAMED20840228302289 EUDAMED20840228302296 EUDAMED20840228302319 EUDAMED20840228301459 EUDAMED
- EMDN Code
- Q02030206,Q02030299,Q0299 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDItaly EUDAMEDTürkiye EUDAMEDPortugal EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
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 Fusion 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 (8)
- EUDAMED 17c91b6d-a441-47f5-92d0-427a2ca8db12 61 fields · synced Aug 1, 2026
- EUDAMED 7cc56336-e1cd-4e6c-88e6-2f4131e260d6 61 fields · synced May 17, 2026
- EUDAMED 8a9f3f06-26a2-4a1d-a027-4a8ff14deaff 61 fields · synced May 17, 2026
- EUDAMED 07488344-9d0d-4d79-b516-6df369afb1f3 61 fields · synced May 18, 2026
- EUDAMED 29696410-ecdc-45b3-be89-cfc8411fb80d 61 fields · synced May 18, 2026
- EUDAMED 05f94e30-625c-45dd-8f29-6af551030dc9 61 fields · synced May 18, 2026
- EUDAMED bdab40cf-7b6f-415d-9741-e0e282854ac4 61 fields · synced May 18, 2026
- EUDAMED 8c792ea0-27df-451e-940a-280dc01c60ae 61 fields · synced May 18, 2026