Identity
- Trade Name
- hasa optix EUDAMED
- Device Name
- IP85068: Sterile, Single Use, CATARACT SET BINA EUDAMED
- Model / Reference
- IP85068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404027445380 EUDAMED
- Basic UDI-DI
- B-05404027445380 EUDAMED
- EMDN Code
- Q021113 OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
hasa optix by Hasa Optix — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-05404027445380 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hasa Optix
- EUDAMED SRN
- BE-MF-000028219
Sources (1)
- EUDAMED d73eaee1-c014-4bc4-97a1-f3a1a1e82fc1 61 fields · synced May 22, 2026