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Optive Gel Drops
EUDAMEDClass IIb (EU MDR)
Ref 95459FHRef 95382CMRef 95382SQRef 95459ITRef 95459EHRef 95459EERef 95382TCRef 95459EW
Identity
- Trade Name
- OPTIVE GEL DROPS EUDAMED
- Device Name
- Dry Eye Comfort Solutions and Ointments EUDAMED
- Model / Reference
- 95459FH EUDAMED95382CM EUDAMED95382SQ EUDAMED95459IT EUDAMED95459EH EUDAMED95459EE EUDAMED95382TC EUDAMED95459EW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10840228302367 EUDAMED10840228301094 EUDAMED10840228301056 EUDAMED10840228302343 EUDAMED10840228302398 EUDAMED10840228301780 EUDAMED10840228301049 EUDAMED10840228302381 EUDAMED
- Basic UDI-DI
- 0840228300034F EUDAMED
- Direct Marketing DI
- 10840228302367 EUDAMED10840228301094 EUDAMED10840228301056 EUDAMED10840228302343 EUDAMED10840228302398 EUDAMED10840228301780 EUDAMED10840228301049 EUDAMED10840228302381 EUDAMED
- EMDN Code
- Q02030206,Q02030299,Q0299 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Luxembourg EUDAMEDItaly EUDAMEDPortugal EUDAMEDLatvia EUDAMEDGermany 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 Gel Drops 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 216a0f57-2da3-47b1-a2d5-e2c197002f87 61 fields · synced Sep 17, 2026
- EUDAMED b2458dca-011c-48a8-a845-5eb44d930e57 61 fields · synced May 16, 2026
- EUDAMED c6625ec5-fc0e-46ea-aa17-5d5eeae9e889 61 fields · synced May 17, 2026
- EUDAMED f6aa83ba-2c94-46a5-bf4d-932a06ad298c 61 fields · synced May 17, 2026
- EUDAMED 9201298e-91b0-4396-9124-5ae346169fb1 61 fields · synced May 18, 2026
- EUDAMED 91aeb128-252c-4e20-b228-c30e52c4180e 61 fields · synced May 18, 2026
- EUDAMED 6c7b3a7f-978b-463c-b6ef-4a79dfe385ae 61 fields · synced May 18, 2026
- EUDAMED 0a86ceb3-1630-4419-92de-3737e3931de7 61 fields · synced May 19, 2026