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(1) 1A1 AaproMel, (2) Optavid, (3) eyeon Hypromellose, (4) AacuLose, (5) lumeca…
EUDAMEDClass IIa (EU MDR)
Ref 1220855Model eyeon Hypromellose
Identity
- Trade Name
- (1) 1A1 AaproMel, (2) Optavid, (3) eyeon Hypromellose, (4) AacuLose, (5) lumecare Hypromellose, (6) FRESH EYE DROP, (7) PharmaBoost Hypromellose 0.3% EUDAMED
- Device Name
- Sterile Hydroxy Propyl Methyl Cellulose Eye Drops 0.3% w/v EUDAMED
- Model / Reference
- eyeon Hypromellose EUDAMED1220855 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-18906040830067PN EUDAMED
- Basic UDI-DI
- B-18906040830067PN EUDAMED
- EMDN Code
- Q02030399 OPHTHALMOLOGY, VISCOELASTIC FLUIDS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
(1) 1A1 AaproMel, (2) Optavid, (3) eyeon Hypromellose, (4) AacuLose, (5) lumeca… by Amanta Healthcare Limited — Class IIa — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18906040830067PN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Amanta Healthcare Limited
- EUDAMED SRN
- IN-MF-000034912
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED b367c436-74ac-49fa-b4a4-7526555a8184 61 fields · synced Jul 26, 2026