Identity
- Trade Name
- SENSITITRE VIZION EUDAMEDSensititre™ Vizion™ FDA UDI
- Generic Name
- Antimicrobial susceptibility analyser IVD FDA UDI
- Device Name
- SENSITITRE VIZION EUDAMEDSensititre™ Vizion™ is an instrument that takes a digital image of a Sensititre susceptibility plate and sends it to the SWIN software, so that the results are displayed at the SWIN PC and can be read by the user. The Sensititre™ Vizion™ is intended for use with the Sensititre™ MIC or BP Susceptibility Test System. The Sensititre™ Vizion™ is an instrument that takes a digital image of a Sensititre susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre™ Vizion™ is an alternate manual reading method for the Sensititre™ MIC plates, and for non-fastidious Gram-positive, Gram-negative, and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp. FDA UDI
- Model / Reference
- V2021 EUDAMEDFDA UDI
- Description
- Sensititre™ Vizion™ is an instrument that takes a digital image of a Sensititre susceptibility plate and sends it to the SWIN software, so that the results are displayed at the SWIN PC and can be read by the user. The Sensititre™ Vizion™ is intended for use with the Sensititre™ MIC or BP Susceptibility Test System. The Sensititre™ Vizion™ is an instrument that takes a digital image of a Sensititre susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre™ Vizion™ is an alternate manual reading method for the Sensititre™ MIC plates, and for non-fastidious Gram-positive, Gram-negative, and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384474509 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384SensititreVizion2N EUDAMED
- FDA Product Code
- JWY FDA UDI
- EMDN Code
- W02030199 ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - 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 Vizion 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 | K112276 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 5032384SensititreVizion2N | 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 b8b8b5d1-2150-4d63-b512-22791822ab8e 61 fields · synced Jul 24, 2026
- FDA UDI 80175b61-731a-4541-893c-10d601e19073 34 fields · synced May 30, 2026
- FDA 510(k) K112276 1 fields · synced May 18, 2026