Data / Medical devices / India / Stemtech Medical Devices Private Limited
Stemtech Medical Devices Private Limited: FDA-registered device maker in Navi Mumbai Maharashtra, India, 1 510(k) clearance
Stemtech Medical Devices Private Limited is registered with the FDA (registration 3044829899) in Navi Mumbai Maharashtra, India. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044829899
- Address
- Unit No.411,4th Floor, Tesla Industrial Building No.1, Tesla, plot no Gen-2/1/C Shriravane Juinagar, Navi Mumbai Maharashtra, India, 400705
- Owner or operator
- Stemtech Medical Devices Private Limited (10095718)
- Roles
- Manufacturer
- First device listed
- April 17, 2026
- Registered through
- 2026
- Brand names listed
- Eva Scalp Cooling System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Scalp Cooling System | PMC | 2 | 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 |
|---|---|---|---|---|---|---|
| November 25, 2025 | K252289 | Eva Scalp Cooling System | PMC | Substantially Equivalent | Stemtech Medical Devices Private Limited | accessdata.fda.gov |
Compare with other makers
Updated November 25, 2025. 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.