Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002532594

FEI Number

3002532594

Entity Name

Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd

City/State/Country

Navi Mumbai Maharashtra, IN

Establishment Address

D-134. T.T.C Industrial Area, Shirvane, Nerul, Navi Mumbai Maharashtra 400706, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd (Owner Number: 9044784)

Owner / Operator Contact Address

D-134. T.T.C Industrial Area, Shirvane, Nerul, Navi Mumbai, IN-NOTA Navi Mumba, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Lumax KIRAN SCREEN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-23
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2019-12-17
IWO	Apron, Protective	Radiology	Class 1	892.6500	2018-04-25
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2019-12-17
EAJ	Apron, Leaded	Radiology	Class 1	892.6500	2019-06-21
IXJ	Grid, Radiographic	Radiology	Class 1	892.1910	2009-10-19
IXA	Cassette, Radiographic Film	Radiology	Class 2	892.1850	2009-04-09
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2001-02-16
EAM	Screen, Intensifying, Radiographic	Radiology	Class 1	892.1960	2001-02-16

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: REGULATORY INSIGHT, INC. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002532594. Last updated year: 2026. Please use registration number 3002532594 when referencing this establishment in official correspondence.