Identity
- Trade Name
- HASA OPTIX EUDAMED
- Device Name
- 654106x10: Sterile, Single Use, Double Ended Manipulator, Koch Stop & Chop/Phaco Chopper, 120mm EUDAMED
- Model / Reference
- 654106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404027421728 EUDAMED
- Basic UDI-DI
- B-05404027421728 EUDAMED
- EMDN Code
- Q021104 OPHTHALMIC SURGERY MANIPULATORS, 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
Category: Ophthalmic surgical probe, single-use
Hasa Optix by Hasa Optix — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical probe, single-use.
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- Epithelial Spatula — BLINK MEDICAL LIMITED · Class I
- S14105 — OPHMED CO., LTD. · Class IIa
- S31264 — OPHMED CO., LTD. · Class IIa
- NUCLEUS Y-HOOK HORIZONTAL 12B — Bausch & Lomb, Inc. · Class I
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- Ophthalmic Hooks — Katena Products, Inc. · Class I
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-05404027421728 | 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 184eee52-6226-48fe-bd82-ae3282dca3d1 61 fields · synced May 21, 2026