Identity
- Trade Name
- Pediatric Fixation Sticks (3pk) EUDAMEDFDA UDI
- Generic Name
- Ophthalmic examination target holder FDA UDI
- Device Name
- Fixation Sticks EUDAMED
- Model / Reference
- 15314 EUDAMED1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- +B091153140X EUDAMEDB091153140 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
Pediatric Fixation Sticks (3pk) 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
- Color Fixation Sticks — Gulden Ophthalmics · Class I
- Face Fixation Sticks (3pk) — Gulden Ophthalmics · Class I
- Fixation Sticks (4pk) — 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 |
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Manufacturer
- Manufacturer
- Gulden Ophthalmics
Sources (2)
- FDA UDI 3e737991-f648-4646-9a87-2794dac4fa91 32 fields · synced Aug 2, 2026
- EUDAMED 9e709de0-aa0f-4f8a-a2db-d05955ed49a2 61 fields · synced Aug 2, 2026