Niramai Health Analytix Private Limited
IndiaFDA applicant, unverified
- Devices
- 3
What Niramai Health Analytix Private Limited makes
Niramai Health Analytix Private Limited manufactures infrared thermography interpretive software, specifically the SMILE-100 System.
The company is based in the US, and its portfolio includes Class I devices that are listed in the FDA 510(k) and FDA UDI registries.
Catalogue
- Registry: GUDID
- Registry: GUDID
Smile-100 System Ref K212965
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 860371138
Frequently asked questions
How many devices does Niramai Health Analytix Private Limited have in the registry?
The registry currently lists 3 devices for Niramai Health Analytix Private Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Niramai Health Analytix Private Limited's devices?
Among its 3 most recently registered devices, Niramai Health Analytix Private Limited has devices listed in 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 Niramai Health Analytix Private Limited's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Niramai Health Analytix Private Limited's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Niramai Health Analytix Private Limited in the registry?
The most recently registered devices listed for Niramai Health Analytix Private Limited include BreastHealth-100 v4.13.0, SMILE-100 System v4.8.0 and Smile-100 System.