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(1) Optavid Advance, (2) 1A1 AaqEye HA, (3) eyeon Hyaluronic, (4) Xailin HA, (5…
EUDAMEDClass IIa (EU MDR)
Ref 1220853Model eyeon Hyaluronic
Identity
- Trade Name
- (1) Optavid Advance, (2) 1A1 AaqEye HA, (3) eyeon Hyaluronic, (4) Xailin HA, (5) Aactive HA, (6) HYALU TEARS Eye Drop EUDAMED
- Device Name
- Sodium Hyaluronate Eye Drops 0.2%w/v EUDAMED
- Model / Reference
- eyeon Hyaluronic EUDAMED1220853 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-18906040830057PK EUDAMED
- Basic UDI-DI
- B-18906040830057PK EUDAMED
- EMDN Code
- Q02030301 OPHTHALMOLOGY, HYALURONIC ACID AND DERIVATIVES 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
Yes
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) Optavid Advance, (2) 1A1 AaqEye HA, (3) eyeon Hyaluronic, (4) Xailin HA, (5… 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-18906040830057PK | 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 83497dd1-3129-4092-8e26-5335cbf91e5b 61 fields · synced Oct 6, 2026