Identity
- Trade Name
- SENSITITRE OPTIREAD EUDAMEDSensititre™ OptiRead™ FDA UDI
- Generic Name
- Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
- Device Name
- SENSITITRE OPTIREAD EUDAMEDThe Sensititre™ OptiRead™ is used to read fluorescent values from Sensititre susceptibility and identification panels. The reading is initiated via the Sensititre SWIN software and the data from the Sensititre™ OptiRead™ are then transferred back to the SWIN software where the results are generated. The device is for professional use only and is not intended for self-testing. FDA UDI
- Model / Reference
- V3030 EUDAMEDFDA UDI
- Description
- The Sensititre™ OptiRead™ is used to read fluorescent values from Sensititre susceptibility and identification panels. The reading is initiated via the Sensititre SWIN software and the data from the Sensititre™ OptiRead™ are then transferred back to the SWIN software where the results are generated. The device is for professional use only and is not intended for self-testing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384474530 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384SensititreOptiR58 EUDAMED
- 510(k) Number
- K110583 FDA UDI
- FDA Product Code
- LRG FDA UDI
- EMDN Code
- W02030199 ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER EUDAMED
- GMDN Term
- Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.1640 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sensititre Optiread by Trek Diagnostic Systems Ltd — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110583 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 5032384SensititreOptiR58 | Class A | Active |
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Manufacturer
- Manufacturer
- Trek Diagnostic Systems Ltd
- EUDAMED SRN
- GB-MF-000016922
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (3)
- EUDAMED e348e741-e681-4091-9957-a485b8e9c1f6 61 fields · synced Jun 18, 2026
- FDA UDI 7d301da6-ec34-4404-87c5-4506b2bb9bc2 35 fields · synced May 30, 2026
- FDA 510(k) K110583 1 fields · synced May 18, 2026