Identity
- Trade Name
- Flashing Fixation Sticks (2pk) EUDAMED
- Device Name
- Fixation Sticks EUDAMED
- Model / Reference
- 15325 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B091153250Z EUDAMED
- Basic UDI-DI
- ++B091FixationSticksGY EUDAMED
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Auditory stimulator
Flashing Fixation Sticks (2pk) by Gulden Ophthalmics — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B091FixationSticksGY | Class I | Active |
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Manufacturer
- Manufacturer
- Gulden Ophthalmics
- EUDAMED SRN
- US-MF-000008608
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED bfc0a213-bd8f-4cd8-8957-1a60d5a95c44 61 fields · synced Jul 21, 2026