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Hasa Optix
EUDAMEDClass IIa (EU MDR)
Ref HA-SET011 X10Model HA-SET011 x10
by Hasa Optix
Identity
- Trade Name
- HASA OPTIX EUDAMED
- Device Name
- HA-SET011 x10: Sterile, Single Use, CATARACT SET RAYNER 11 EUDAMED
- Model / Reference
- HA-SET011 x10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404027446615 EUDAMED
- Basic UDI-DI
- B-05404027446615 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-05404027446615 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hasa Optix
- EUDAMED SRN
- BE-MF-000028219
Sources (1)
- EUDAMED 30be5746-7a3f-49ce-9bfe-5faa466fcbc1 61 fields · synced May 21, 2026