Identity
- Trade Name
- hasa optix EUDAMED
- Device Name
- IP85074: Sterile, Single Use, DR. RIGHETTI SET EUDAMED
- Model / Reference
- IP85074 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404027445434 EUDAMED
- Basic UDI-DI
- B-05404027445434 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 medical device is a sterile, single-use instrument used in endocrinology to measure glucose levels. It has been designed for use in critical care settings and is available for direct marketing by authorized distributors.
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-05404027445434 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hasa Optix
- EUDAMED SRN
- BE-MF-000028219
Sources (1)
- EUDAMED aeb98cd5-b5ef-4e33-a8e1-80dd9865813d 61 fields · synced Jul 21, 2026