Identity
- Trade Name
- HASA OPTIX EUDAMED
- Device Name
- IP85251: Sterile, Single Use, SFZ Strabismus Set EUDAMED
- Model / Reference
- IP85251 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404027449074 EUDAMED
- Basic UDI-DI
- B-05404027449074 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
The HASA OPTIX device is a sterile, single-use Strabismus Set used in the treatment of strabismus, a condition where one or more eyes are misaligned. Developed for precision and sterility, this device has been designed with advanced technology to provide accurate and effective results.
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-05404027449074 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hasa Optix
- EUDAMED SRN
- BE-MF-000028219
Sources (1)
- EUDAMED 97a28759-15f3-473c-8451-08ca05feed36 61 fields · synced Jul 23, 2026