Data / Medical devices / India / Phoenix Innovative Healthcare Manufacturers Private Limited
Phoenix Innovative Healthcare Manufacturers Private Limited: FDA-registered device maker in Navi Mumbai Maharashtra, India, 1 510(k) clearance
Phoenix Innovative Healthcare Manufacturers Private Limited is registered with the FDA (registration 3010408344) in Navi Mumbai Maharashtra, India. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 30, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010408344
- Address
- EL-209, Shil Mahape Road Electronic Zone; MIDC TTC Industry Area, Mahape, Navi Mumbai Maharashtra, India, 400710
- Owner or operator
- Phoenix Innovative Healthcare Manufacturers Private Limited (10044216)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 22, 2015
- Registered through
- 2026
- Brand names listed
- Digital Thermometer DT-04, Digital Thermometer DT-06, Digital Thermometer DT-07, Digital Thermometer PHX-01, Phoenix Contact lens case, SI31
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Case, Contact Lens | LRX | 2 | Manufacturer | accessdata.fda.gov |
| Clinical Electronic Thermometer | SDV | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 30, 2023 | K231123 | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) | LRX | Substantially Equivalent | Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Case, Contact Lens
- All makers of Clinical Electronic Thermometer
- All makers of Pad, Alcohol, Device Disinfectant
- All makers of Humidifier, Non-Direct Patient Interface (Home-Use)
Updated August 30, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.