Identity
- Trade Name
- LED Worth Four Dot Test EUDAMED
- Device Name
- Diplopia Tests EUDAMED
- Model / Reference
- 15304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B091153040W EUDAMED
- Basic UDI-DI
- ++B091DiplopiaTest5C EUDAMED
- EMDN Code
- Q0209 STRABISMUS DEVICES 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
LED Worth Four Dot Test by Gulden Ophthalmics — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++B091DiplopiaTest5C | 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 5b101acb-5ad5-4103-a0ca-7b6075c12565 61 fields · synced Jul 13, 2026