Identity
- Trade Name
- HASA OPTIX EUDAMED
- Device Name
- 555003: Sterile, Single Use, Wire Speculum, 13.5mm Open Blades, L 52mm EUDAMED
- Model / Reference
- 555003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404027412375 EUDAMED
- Basic UDI-DI
- B-05404027412375 EUDAMED
- EMDN Code
- Q021106 OPHTHALMIC SURGERY DILATORS, 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-05404027412375 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hasa Optix
- EUDAMED SRN
- BE-MF-000028219
Sources (1)
- EUDAMED cde2a86c-d99b-4383-9e98-347b3530a4f8 61 fields · synced May 22, 2026