Time Medical Limited
Active in EUDAMEDChinaFDA applicant, unverified EUDAMED SRN HK-MF-000019852
- Devices
- 7
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Time Medical Limited makes
Time Medical Limited manufactures magnetic resonance imaging (MRI) systems, including 1.5T MRI units for general use (EMMA and NEONA), a whole-body MRI system (PICA), and an orthopedic-focused MRI system (MONA). These devices are designed for diagnostic imaging in clinical and research settings, with models tailored for specific applications like whole-body scans and musculoskeletal assessments.
The company’s MRI systems are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The portfolio is listed in the FDA’s 510(k) database, reflecting regulatory compliance for these imaging devices. Time Medical Limited is based in the United States.
Catalogue
Pica Ref TMS-MRI-3500WB
Regimes: CE MDD Registry: EUDAMEDEMMA 1.5T MRI System Ref K183621
Regimes: 510(k) Registry: 510(k)NEONA 1.5T MRI System Ref K222259
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Pica Whole Body Mri System Ref K091580
Regimes: 510(k) Registry: 510(k)Pica Whole-Body Mri System Ref K110942
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- HK-MF-000019852
- EUDAMED status
- Active
- EUDAMED registered name
- Time Medical Limited
- Registered address
- 2, Science Park Ave, 00000, Shatin, Hong Kong
- [email protected]
- Phone
- +852 2156 1711
- PRRC contact
- N Tse
Frequently asked questions
How many devices does Time Medical Limited have in the registry?
The registry currently lists 7 devices for Time Medical Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Time Medical Limited's devices?
Among its 7 most recently registered devices, Time Medical Limited has devices listed in EUDAMED (1 device) and FDA 510(k) (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Time Medical Limited's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Time Medical Limited's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Time Medical Limited in the registry?
The most recently registered devices listed for Time Medical Limited include Pica, EMMA 1.5T MRI System, NEONA 1.5T MRI System and PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01.