Exact Imaging
Active in EUDAMEDCanadafrom SRN EUDAMED FDA SRN CA-MF-000004363
Exact Imaging is a medical device manufacturer based in Canada, with 16 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II) as of 13 Nov 2026.
- Devices
- 16
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 12
- FDA 510(k) 4
- EUDAMED 2
- Device classes
- FDA Class II 16
- Identifiers
- EUDAMED SRN CA-MF-000004363
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Exact Imaging makes
Exact Imaging manufactures reusable and single-use needle guides for procedural precision, including sterile and non-sterile variants for transrectal, transperineal, and general use. Their portfolio also includes high-resolution micro-ultrasound systems and specialized transducers for abdominal, rectal, and vaginal imaging, as well as hand-held extracorporeal ultrasound devices.
All products fall under FDA Class II regulation and are authorised via the 510(k) pathway and the FDA’s Unique Device Identification (UDI) system.
Catalogue
Search and filter all 16 devicesCompany details
- EUDAMED SRN
- CA-MF-000004363
- EU VAT number
- BE0671711043
- EUDAMED status
- Active
- EUDAMED registered name
- Exact Imaging Inc.
- Registered address
- 7676, Woodbine Ave, L3R 2N2, Markham, Canada
- Website
- www.exactimaging.com
- Phone
- +1 905 415 0030
- PRRC contact
- Randy AuCoin
FDA establishments
- Exact Imaging, Inc. Markham Ontario · CA FEI 3012402886
Frequently asked questions
How many devices does Exact Imaging have in the registry?
The registry currently lists 16 devices for Exact Imaging. Devices recorded under merged duplicate company entries are counted once.
Which registries list Exact Imaging's devices?
Among its 16 most recently registered devices, Exact Imaging has devices listed in EUDAMED (2 devices), FDA 510(k) (4 devices) and FDA GUDID (12 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Exact Imaging's devices fall under?
Among its 16 most recently registered devices, the classes recorded for Exact Imaging's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Exact Imaging in the registry?
The most recently registered devices listed for Exact Imaging include EV29L Non-Sterile Reusable Transperineal Needle Guide EV-TPRG, Non-Sterile Reusable Needle Guide - 16GA EV-BIOG-R16, EV5C Abdominal Transducer and ExactVu High Resolution Micro-Ultrasound System 1.0.
Which FDA establishments are linked to Exact Imaging?
1 FDA establishment is linked to Exact Imaging in the registry; they are listed on the company page.