Identity
- Trade Name
- SENSITITRE ARIS HIQ SYSTEM EUDAMEDThermo Scientific™ Sensititre™ ARIS HiQ™ System FDA UDI
- Generic Name
- Microorganism identification/antimicrobial-susceptibility analyser IVD FDA UDI
- Device Name
- SENSITITRE ARIS HIQ SYSTEM EUDAMEDThe Thermo Scientific™ Sensititre™ ARIS HiQ™ System is a benchtop automated incubation and reading system for antimicrobial susceptibility testing and identification of bacterial pathogens; designed to accommodate up to 100 Sensititre™ microtitre plates within a single instrument. FDA UDI
- Model / Reference
- V4000 EUDAMEDFDA UDI
- Description
- The Thermo Scientific™ Sensititre™ ARIS HiQ™ System is a benchtop automated incubation and reading system for antimicrobial susceptibility testing and identification of bacterial pathogens; designed to accommodate up to 100 Sensititre™ microtitre plates within a single instrument. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384545872 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384SensititreARISHQ2V EUDAMED
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sensititre Aris Hiq System by Trek Diagnostic Systems Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5032384SensititreARISHQ2V | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 (2)
- EUDAMED 22dd675f-38f8-4c92-9cec-1dbb5d049864 61 fields · synced Jun 18, 2026
- FDA UDI f9b7a2d4-cc63-43b3-a3c3-2a21cfb40bc8 35 fields · synced May 30, 2026