Face Fixation Sticks (3pk)
by Gulden Ophthalmics EUDAMED
Active
Ref 15315
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++B091FixationSticksGY | Date19 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Fixation Sticks
- Model / Reference
- 15315
- Primary DI / UDI-DI
- +B091153150Y
- Basic UDI-DI
- ++B091FixationSticksGY
- EMDN Code
- Z129013 General auditory and/or visual stimulators
- Device Class
- Class I
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000008608
- Authorised representative
- QbD RepS BV BE-AR-000000040
Other devices from Gulden Ophthalmics
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No