Resonance Health Analysis Services
Active in EUDAMEDAustraliafrom SRN EUDAMED SRN AU-MF-000026337
- Devices
- 9
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- Authorised rep.
- Advena LimitedMT
What Resonance Health Analysis Services makes
Resonance Health Analysis Services manufactures phantoms and diagnostic imaging tools for quantitative analysis, including T1 and T2 cardiac magnetic resonance (CMR) phantoms for 1.5T and 3.0T scanners, as well as liver iron concentration and fat quantification devices such as HepaFatScan and FerriScan. Their portfolio also includes R2* and T2* phantoms, alongside combined imaging solutions like ImageR2, which integrates FerriScan and cardiac T2* assessments.
The company’s devices are classified under EU medical device regulations as Class I and Class IIa, with products listed in the EU’s eudamed registry. Resonance Health Analysis Services operates from Australia, adhering to regulatory requirements for imaging phantoms and diagnostic software used in clinical and research settings.
Catalogue
T2CMR Phantom Ref 000716
Regimes: CE MDR Registry: EUDAMEDT1CMR Phantom (3.0T) Ref 000648
Regimes: CE MDR Registry: EUDAMEDHepaFatScan Ref Version 1.1.0
Regimes: CE MDR Registry: EUDAMEDR2*/T2* Phantom Ref 000884
Regimes: CE MDR Registry: EUDAMEDHepaFatSmart Ref Version 2.0.0
Regimes: CE MDR 510(k) Registry: EUDAMED510(k)FerriScan Phantom Ref 000266
Regimes: CE MDR Registry: EUDAMEDFerriSmart Ref Version 2.2.4
Regimes: CE MDR 510(k) Registry: EUDAMED510(k)T1CMR Phantom (1.5T) Ref 000334
Regimes: CE MDR Registry: EUDAMEDImageR2 (FerriScan and CardiacT2*) Ref Version 4.0.0
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- AU-MF-000026337
- EUDAMED status
- Active
- EUDAMED registered name
- Resonance Health Analysis Services
- EUDAMED abbreviated name
- RHT
- Registered address
- 141, Burswood Road, 6100, Burswood, Australia
- Website
- www.resonancehealth.com
- [email protected]
- Phone
- +61 413428136
- PRRC contact
- Bronte Maddock
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 21 Aug 2030
DQS Medizinprodukte GmbH 0297 1 certificate
- 1000316512 Active
Quality management system EU MDR
- Issued
- 13 May 2026
- Expires
- 21 Aug 2030
- Reason
- Change approved
From the company website
Resonance Health offers advanced imaging solutions that enable doctors to enhance decision-making, tailor patient care, and achieve superior outcomes.
Frequently asked questions
How many devices does Resonance Health Analysis Services have in the registry?
The registry currently lists 9 devices for Resonance Health Analysis Services. Devices recorded under merged duplicate company entries are counted once.
Which registries list Resonance Health Analysis Services's devices?
Among its 9 most recently registered devices, Resonance Health Analysis Services has devices listed in EUDAMED (9 devices) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Resonance Health Analysis Services's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Resonance Health Analysis Services's devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Resonance Health Analysis Services?
EUDAMED lists 1 certificate for Resonance Health Analysis Services (quality management system) under MDR. The most recent was issued on 13 May 2026.
What are the newest devices from Resonance Health Analysis Services in the registry?
The most recently registered devices listed for Resonance Health Analysis Services include T2CMR Phantom, T1CMR Phantom (3.0T), HepaFatScan and R2*/T2* Phantom.