Hasa Optix
Ref 552040
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
The HASA OPTIX medical device is a sterile, single-use blade breaker with a curved, round knurled handle and an end lock for secure attachment to a syringe or needle. It is designed for use in operating rooms and emergency departments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-05404027417493 | Date26 Jan 2023 | 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- Withdrawn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
- 552040x10: Sterile, Single Use, Blade Breaker, Curved, Round Knurled Handle With End Lock, 120mm552040: Sterile, Single Use, Blade Breaker, Curved, Round Knurled Handle With End Lock, 120mm
- Model / Reference
- 552040
- Primary DI / UDI-DI
- 05404027417493, 05404027402666
- Basic UDI-DI
- B-05404027417493, B-05404027402666
- EMDN Code
- Q021199 Ophthalmic surgery instruments, single-use - other
- 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