Data / Medical devices / India / Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd
Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd: FDA-registered device maker in Navi Mumbai Maharashtra, India, 1 510(k) clearance
Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd is registered with the FDA (registration 3002532594) in Navi Mumbai Maharashtra, India. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 7, 1990. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3002532594
- Address
- D-134. T.T.C Industrial Area Shirvane, Nerul, Navi Mumbai Maharashtra, India, 400706
- Owner or operator
- Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd (9044784)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 16, 2001
- Registered through
- 2026
- Brand names listed
- Anti Scatter Grids, Face Mask, Fujifilm Cassette F Series, Fujifilm Cassette FW Series, KIRAN, KIRAN PROTECTIVE APPAREL, KIRAN SCREEN, KIRAN-Leadlite and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Apron, Leaded | EAJ | 1 | Manufacturer | accessdata.fda.gov |
| Apron, Protective | IWO | 1 | Manufacturer | accessdata.fda.gov |
| Cassette, Radiographic Film | IXA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Grid, Radiographic | IXJ | 1 | Manufacturer | accessdata.fda.gov |
| Light, Surgical, Ceiling Mounted | FSY | 2 | Manufacturer | accessdata.fda.gov |
| Radiographic Protective Glove | IWP | 1 | Manufacturer | accessdata.fda.gov |
| Screen, Intensifying, Radiographic | EAM | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Eye, Radiological | IWS | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
| Table, Operating-Room, Electrical | GDC | 1 | 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 |
|---|---|---|---|---|---|---|
| May 7, 1990 | K896708 | PERLINK CASSETTE, KIRAN CASSETTE | IXA | Substantially Equivalent | Perlink USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cassette, Radiographic Film
- All makers of Shield, Eye, Radiological
- All makers of Apron, Leaded
- All makers of Table, Operating-Room, Electrical
- All makers of Shield, Protective, Personnel
- All makers of Apron, Protective
Updated May 7, 1990. 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.