Identity
- Trade Name
- SENSITITRE AIM EUDAMEDSensititre AIM™ FDA UDI
- Generic Name
- Antimicrobial susceptibility analyser IVD FDA UDI
- Device Name
- SENSITITRE AIM EUDAMEDThe product trade name is Sensititre AIM™. The product is a microprocessor-controlled automated inoculation delivery system. It is designed to deliver, through a disposable dosing head, multiples of 50 µL inoculum to a Sensititre 96-well microtitration plate for in vitro antimicrobial susceptibility testing and/or identification of pathogenic microorganisms. Sensititre AIM is for professional use only and is not intended for self-testing.The performance of Sensititre AIM to inoculate standard 96-well microtitration plates (non-Sensititre plates) has not been established. Although other brands of 96-well microtitration plates may be used on the AIM instrument, they must be pre-qualified before use. FDA UDI
- Model / Reference
- V3020 EUDAMEDFDA UDI
- Description
- The product trade name is Sensititre AIM™. The product is a microprocessor-controlled automated inoculation delivery system. It is designed to deliver, through a disposable dosing head, multiples of 50 µL inoculum to a Sensititre 96-well microtitration plate for in vitro antimicrobial susceptibility testing and/or identification of pathogenic microorganisms. Sensititre AIM is for professional use only and is not intended for self-testing.The performance of Sensititre AIM to inoculate standard 96-well microtitration plates (non-Sensititre plates) has not been established. Although other brands of 96-well microtitration plates may be used on the AIM instrument, they must be pre-qualified before use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384497409 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384SensititreAIM4S EUDAMED
- FDA Product Code
- LIE FDA UDILRG FDA UDIJWY FDA UDI
- EMDN Code
- W02039099 VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- 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 Aim 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 | 5032384SensititreAIM4S | 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 7e2d3e52-d5dc-4f9f-b1f9-93f2b2cf51d0 61 fields · synced Jul 8, 2026
- FDA UDI 6249dd0d-6772-49e2-aaa8-894649a9bafc 35 fields · synced May 30, 2026