Identity
- Trade Name
- Color Fixation Sticks EUDAMEDFDA UDI
- Generic Name
- Ophthalmic examination target holder FDA UDI
- Device Name
- Fixation Sticks EUDAMED
- Model / Reference
- 15176 EUDAMED1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- +B091151760$ EUDAMEDB091151760 FDA UDI
- Basic UDI-DI
- ++B091FixationSticksGY EUDAMED
- FDA Product Code
- HPL FDA UDI
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
- GMDN Term
- Ophthalmic examination target holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1290 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic examination target holder
Color Fixation Sticks by Gulden Ophthalmics — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic examination target holder.
- Flashing Fixation Sticks (2pk) — Gulden Ophthalmics · Class I
- Pediatric Fixation Wand — Gulden Ophthalmics · Class I
- Peds Pack — Gulden Ophthalmics · Class I
- Flashing Butterfly Fixation Stick — Gulden Ophthalmics · Class I
- Face Fixation Sticks (3pk) — Gulden Ophthalmics · Class I
- Fixation Sticks (4pk) — Gulden Ophthalmics · Class I
- Pediatric Fixation Sticks (3pk) — Gulden Ophthalmics · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gulden Ophthalmics
Sources (2)
- FDA UDI 011f041d-edfc-4cae-a089-c2780b19b855 32 fields · synced Jul 17, 2026
- EUDAMED 0cab49c2-7376-42ce-9a8a-8dc1b4884551 61 fields · synced Jul 17, 2026