Hasa Optix
Ref IP85235 x10
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
The HASA OPTIX device is a medical device designed to treat glaucoma. It is a sterile, single-use implantable device that helps to reduce intraocular pressure in patients with glaucoma.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-15404027448975 15404027448975 | Date20 Jun 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- IP85235 x10: Sterile, Single Use, Glaucom Set 1
- Model / Reference
- IP85235 x10
- Primary DI / UDI-DI
- 15404027448975
- Basic UDI-DI
- B-15404027448975
- EMDN Code
- Q021113 Ophthalmic surgery instrument kits, single-use
- Device Class
- Class IIa
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000028219
Other devices from Hasa Optix
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No