← Back to catalogue
Auto Kerato-Refracto Tonometer Trk-3 Omnia
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref TRK-3 OMNIA
Identity
- Trade Name
- AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA EUDAMED
- Device Name
- AUTO KERATO-REFRACTO TONOMETER EUDAMED
- Model / Reference
- TRK-3 OMNIA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571130283213 EUDAMED04560126268860 EUDAMED
- Basic UDI-DI
- 4560126260010TS EUDAMED
- EMDN Code
- Z12120122 TONOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Auto Kerato-Refracto Tonometer Trk-3 Omnia by Topcon Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253039 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4560126260010TS | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Topcon Corporation
- EUDAMED SRN
- JP-MF-000003928
- Authorised Representative
- Topcon Europe Medical BV NL-AR-000000441
Sources (3)
- EUDAMED 94342ca8-5e51-47a4-8c10-b53b0fd87a61 61 fields · synced Jul 23, 2026
- EUDAMED 988125c7-5585-4de5-93c8-c687729c6143 61 fields · synced May 19, 2026
- FDA 510(k) K253039 1 fields · synced May 18, 2026