FDA Registration
Active
🇮🇳 India
Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd
Reg #: 3002532594
·
FEI: 3002532594
·
Expires 2026
Products
11
Proprietary Names
27
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd
- Registration Number
- 3002532594
- FEI Number
- 3002532594
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- D-134. T.T.C Industrial Area, Shirvane, Nerul
- City
- Navi Mumbai Maharashtra
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K896708
Owner / Operator
- Firm Name
- Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd
- Operator Number
- 9044784
- Address
- D-134. T.T.C Industrial Area, Shirvane, Nerul
- City
- Navi Mumbai
- State
- IN-NOTA
- Postal Code
- Navi Mumba
- Country
- IN
US Agent
- Business Name
- REGULATORY INSIGHT, INC.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-23 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2019-12-17 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2018-04-25 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2019-12-17 |
| Apron, Leaded | EAJ | Class 1 | Radiology | No | 2019-06-21 |
| Grid, Radiographic | IXJ | Class 1 | Radiology | No | 2009-10-19 |
| Cassette, Radiographic Film | IXA | Class 2 | Radiology | No | 2009-04-09 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2001-02-16 |
| Screen, Intensifying, Radiographic | EAM | Class 1 | Radiology | No | 2001-02-16 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 2008-04-21 |
| Shield, Eye, Radiological | IWS | Class 1 | Radiology | No | 2022-06-15 |
Proprietary Names
Protective Coveralls
Face Mask
Operation Theatre Lights
KIRAN-Leadlite
KIRAN-Zerolead
KIRAN-Zerolead Air
KIRAN-Ultralite
Operation Theatre Table
Soothe-Guard Air
Soothe-Guard
Anti Scatter Grids
Fujifilm Cassette FW Series
Fujifilm Cassette F Series
Lumax
KIRAN PROTECTIVE APPAREL
Protec
Medlink
KIRAN SCREEN
KIRAN
Prote-X
Kiran Cassette
Kiran Fitover -Shield, Eye, Radiological
Kiran-Max 10 -Shield, Eye, Radiological
Kiran- Front- Shield, Eye, Radiological
Kiran-Max 30 -Shield, Eye, Radiological
Kiran- Aviator -Shield, Eye, Radiological
Kiran-Front and Side -Shield, Eye, Radiological
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)