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Hasa Optix [EN]
EUDAMEDClass IIa (EU MDR)
Ref IP85186Ref IP85187Model IP85187 x10Ref IP85174Ref IP85197Ref HA-SET028Model HA-SET028 x10Model IP85197 x 10
by Hasa Optix
Identity
- Trade Name
- Hasa Optix [EN] EUDAMED
- Device Name
- Sterile, Single Use, Cataract Set CHw 1 EUDAMEDSterile, Single Use, Cataract Set CHw 2 EUDAMEDIP85174: Sterile, Single Use, Pack Instrumenten Elien Willekens EUDAMEDSterile, Single Use, ICL Set Dr Guber EUDAMEDHA-SET028 x10:Sterile, Single Use,CATARACT SET RAYNER 28 EUDAMED
- Model / Reference
- IP85186 EUDAMEDIP85187 x10 EUDAMEDIP85187 EUDAMEDIP85174 EUDAMEDIP85197 EUDAMEDHA-SET028 x10 EUDAMEDHA-SET028 EUDAMEDIP85197 x 10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404027448480 EUDAMED05404027448510 EUDAMED05404027448466 EUDAMED05404027448527 EUDAMED05404027448459 EUDAMED05404027448534 EUDAMED05404027448503 EUDAMED
- Basic UDI-DI
- B-05404027448480 EUDAMEDB-05404027448510 EUDAMEDB-05404027448466 EUDAMEDB-05404027448527 EUDAMEDB-05404027448459 EUDAMEDB-05404027448534 EUDAMEDB-05404027448503 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 [EN] 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-05404027448480 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hasa Optix
- EUDAMED SRN
- BE-MF-000028219
Sources (7)
- EUDAMED c89db90b-652d-466a-93c7-cd64d758e94c 61 fields · synced Aug 3, 2026
- EUDAMED a40d46f5-a799-4510-9248-e862900a8ce6 61 fields · synced May 17, 2026
- EUDAMED ae569984-f880-4f13-bb84-ef8fc5d6caab 61 fields · synced May 17, 2026
- EUDAMED eed76b63-cd91-48dc-9a42-0243b4446f89 61 fields · synced May 17, 2026
- EUDAMED 27d0c80e-ca5c-4d3f-af47-1941d1e720f4 61 fields · synced May 18, 2026
- EUDAMED b452b8c0-7eb3-4663-99d4-1ab1517e0853 61 fields · synced May 18, 2026
- EUDAMED dca2b576-12f7-4860-b672-48f3ec451c4d 61 fields · synced May 19, 2026