Painchek Ltd
Active in EUDAMEDAustraliafrom SRN EUDAMED FDA SRN AU-MF-000034893 FEI 3022518366
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
PainChek (PainChek Adult) Ref DEN240073
De Novo 510(k)PainChek Ref PainChek Infant (iOS Version)
CE MDD EUDAMEDPainChek Ref PainChek Adult (Android Version)
CE MDD EUDAMEDGUDIDPainChek Ref PainChek Adult (iOS Version)
CE MDD EUDAMEDGUDID
Company details
- EUDAMED SRN
- AU-MF-000034893
- FDA FEI number
- 3022518366
- DUNS number
- 744664996
- EUDAMED status
- Active
- EUDAMED registered name
- PainChek Ltd.
- EUDAMED abbreviated name
- PainChek Ltd.
- Registered address
- 35, Lime Street, NSW 2000, Sydney, Australia
- Website
- www.painchek.com
- [email protected]
- Phone
- +61 1800 098 809
- PRRC contact
- Caleb Ng
Frequently asked questions
How many devices does PAINCHEK LTD have in the registry?
The registry currently lists 4 devices for PAINCHEK LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list PAINCHEK LTD's devices?
Among its 4 most recently registered devices, PAINCHEK LTD has devices listed in EUDAMED (3 devices), FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do PAINCHEK LTD's devices fall under?
Among its 4 most recently registered devices, the classes recorded for PAINCHEK LTD's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from PAINCHEK LTD in the registry?
The most recently registered devices listed for PAINCHEK LTD include PainChek (PainChek Adult) and PainChek.