Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015223105

FEI Number

3015223105

Entity Name

GALAXY INDIA

City/State/Country

NEW DELHI, IN

Establishment Address

T-5/237, MANGOLPURI INDL. AREA, PHASE-1, NEW DELHI 110083, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GALAXY INDIA (Owner Number: 10059711)

Owner / Operator Contact Address

T-5/237, MANGOLPURI INDL. AREA, PHASE-1, NEW DELHI, IN-DL 110083, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KIARA 700/700/700, KIARA 700/700/700 WITH CAMERA AND MONITOR,KIARA 700/700/500,KIARA 700/700/500 WITH CAMERA AND MONITOR KIARA 500/500, KIARA 500/500 WITH CAMERA AND MONITOR, KIARA 700, KIARA 600, KIARA 500, KIARA 300 ALINA 5+3, ALINA 5+3 WITH CAMERA AND MONITOR, ALINA 4+3, ALINA 4+3 WITH CAMERA AND MONITOR ALINA 3+3 KIARA 12, KIARA 9, ALINA 5+5+5, ALINA 5+5+5 WITH CAMERA AND MONITOR, ALINA 5+5+3, ALINA 5+5+3 WITH CAMERA AND MONITOR ALINA 5+5, ALINA 5+5 WITH CAMERA AND MONITOR, ALINA 5+4, ALINA 5+4 WITH CAMERA AND MONITOR ALINA 3+3 WITH CAMERA AND MONITOR, ALINA 5, ALINA 4, ALINA 3, ALINA 12, ALINA 9 KIARA 700/700, KIARA 700/700 WITH CAMERA AND MONITOR, KIARA 700/500, KIARA 700/500 WITH CAMERA AND MONITOR GALAXY INDIA Surgical Shadowless Operating Light Ceiling Mounted 700/700 WITH CAMERA AND MONITOR, 700/500 WITH CAMERA 700/700/700 WITH CAMERA AND MONITOR 700/500/500 WITH CAMERA, 700/500/500 WITH CAMERA AND MONITOR 700/700/700, 700/700/500, 700/500/500, 700/700/700 WITH CAMERA 700/700 WITH CAMERA, 700/700 WITH CAMERA AND MONITOR 700/700/500 WITH CAMERA, 700/700/500 WITH CAMERA AND MONITOR 700/500 WITH CAMERA AND MONITOR, 700/700, 500/500, 700/500, 700, 500 GALAXY INDIA Surgical Operating Table Manual RELAX, RELAX ADVANCE, RELIEF, RELIEF ADVANCE, SURGICAL TABLE ACCESSORIES FOR GENERAL SURGERY ENT, GYNAECOLOGY, UROLOGY, ORTHOPAEDICS, TRUMATOLOGY, SPINAL SURGERY, NEUROSURGERY, GAS SPRING ASSISTED POWER STIRRUPS ACURA, ACURA ADVANCE, ACURA ADVANCE PLUS, ACURA PRO,ACURA-SL, ACURA-SL ADVANCE, ACURA-SL PRO, ACURA-BR,ACURA-BR ADVANCE GALAXY INDIA Surgical Operating Table AC Powered ACURA-BR PRO, ECOLINE, ECOLINE ADVANCE, ECOLINE PRO, ECOLINE-SL, ECOLINE-SL ADVANCE, ECOLINE-SL PRO, STYLA AURIS, AURIS ADVANCE, AURIS ADVANCE PLUS, AURIS PRO, AURIS-SL, AURIS-SL ADVANCE, AURIS-SL PRO, AURIS-BR, AZURE-SL ADVANCE, AZURE-SL PRO,AZURE-BR, AZURE-BR ADVANCE, AZURE-BR PRO, AZURE-ESWL, AZURE-ESWL ADVANCE, AZURE-ESWL PRO, ASIRA, ASIRA ADVANCE, ASIRA PRO, ASIRA-SL, ASIRA-SL ADVANCE, ASIRA-SL PRO, ASIRA-BR, ASIRA-BR ADVANCE ASIRA-BR PRO, ASIRA-ESWL, ASIRA-ESWL ADVANCE, ASIRA-ESWL PRO, AZURE, AZURE ADVANCE, AZURE PRO, AZURE-SL, SPINAL SURGERY, NEUROSURGERY, GAS SPRING ASSISTED POWER STIRRUPS AURIS-BR ADVANCE, AURIS-BR PRO,STYLA ADVANCE, STYLA PRO, AURA, AURA ADVANCE, AURA PRO, SURGICAL TABLE ACCESSORIES FOR GENERAL SURGERY, ENT, GYNAECOLOGY, UROLOGY, ORTHOPAEDICS, TRUMATOLOGY ASIRA, ASIRA ADVANCE, ASIRA PRO, ASIRA-SL, ASIRA-SL ADVANCE, ASIRA-SL PRO, ASIRA-BR, ASIRA-BR ADVANCE, ASIRA-BR PRO, AURIS-SL PRO, AURIS-BR, AURIS-BR ADVANCE, AURIS-BR PRO,ACURA, ACURA ADVANCE, ACURA ADVANCE PLUS HIP NAILING SUPPORT, RADIO-TRANSLUCENT HAND OPERATING TABLE, STEINMANN PIN HOLDING CLAMP, SHOULDER SURGERY ATTACHMENT BACK-BUTTOCKS SUPPORT, PUBIS-SACRUM-STERNUM SUPPORT, ARTHROSCOPY POSITIONING DEVICE, KNEE CHEST POSITIONING DEVICE, ASIRA-ESWL, ASIRA-ESWL ADVANCE, ASIRA-ESWL PRO, AZURE, AZURE ADVANCE, AZURE PRO, AZURE-SL, AZURE-SL ADVANCE AZURE-SL PRO, AZURE-BR, AZURE-BR ADVANCE, AZURE-BR PRO, AZURE-ESWL GALAXY INDIA Surgical Operating Table AC Powered with Orthopedic Accessories ECOLINE, ECOLINE ADVANCE, ECOLINE PRO, ECOLINE-SL, ECOLINE-SL ADVANCE, ECOLINE-SL PRO SURGICAL TABLE ACCESSORIES, LEG TRACTION DEVICE, HAND TRACTION DEVICE, POPLITEAL SUPPORT, TIBIA SUPPORT AZURE-ESWL ADVANCE, AZURE-ESWL PRO, AURIS, AURIS ADVANCE, AURIS ADVANCE PLUS, AURIS PRO, AURIS-SL, AURIS-SL ADVANCE LATERAL ARMREST, SPINAL BRIDGE WILSON, SPINAL FRAME, MAYFIELD 3 PIN SKULL CLAMP, SUGITA 4 PIN SKULL CLAMP STYLA,STYLA ADVANCE, STYLA PRO, AURA, AURA ADVANCE, AURA PRO LEYLA RETRACTOR SYSTEM, HORSESHOE HEADREST ACURA PRO, ACURA-SL, ACURA-SL ADVANCE, ACURA-SL PRO, ACURA-BR, ACURA-BR ADVANCE, ACURA-BR PRO GALAXY INDIA LED X-Ray Film Viewer LED X-RAY FILM VIEWER BACK LIT MODELS: XB1, XB2, XB3, XB4, LED X-RAY FILM VIEWER SIDE LIT MODELS: XS1, XS2, XS3, XS4 GALAXY INDIA Bed Side Cabinet GI 101, GI 102, GI 103, GI 104, GI 105 SEMI FOWLER BED MODELS: GI 1000, GI 2000, DELIVERY BED MODELS: GI 111, GI 222, GI 333, WHEEL CHAIR ICU BED MODELS: GI 5000, GI 6000, GI 7000, GI 8000, FOWLER BED MODELS: GI 3000, GI 4000 GALAXY INDIA Hospital Bed Manual GALAXY INDIA Hospital Bed AC Powered SEMI FOWLER BED MODELS: GI 1100, GI 2100, DELIVERY BED MODELS: GI 555, GI 666, GI 777, WHEEL CHAIR ICU BED MODELS: GI 5100, GI 6100, GI 7100, GI 8100, FOWLER BED MODELS: GI 3100, GI 4100, KIARA 12M, KIARA 12M WITH BATTERY BACK-UP, KIARA 9M, KIARA 9M WITH BATTERY BACK-UP, KIARA 6M, GALAXY INDIA Surgical Examination Light Mobile KIARA 6M WITH BATTERY BACK-UP, ALINA 12M, ALINA 12M WITH BATTERY BACK-UP, ALINA 9M, ALINA 9M WITH BATTERY BACK-UP ALINA 6M, ALINA 6M WITH BATTERY BACK-UP GALAXY INDIA Patient Positioning Gel Pads DOME POSITIONER GEL, UNIVERSAL POSITIONER GEL, FLAT BOTTOM CHEST ROLL GEL, LATERAL POSITIONER GEL, ELBOW PROTECTOR GEL SACRAL PROTECTOR GEL, CONTOURED ARM REST GEL, FLAT ARM REST GEL, KNEE PAD GEL, CONTOURED LEG REST GEL, CRUTCH PAD GEL MINI HEAD BASE RING GEL, MINI HORSESHOE HEAD RING GEL, NEONATAL ROLL GEL, NEONATAL HEAD CRADLE GEL HEEL SUPPORT GEL, UNIVERSAL GEL PAD, UNIVERSAL OPERATING TABLE GEL PAD, PRONE POSITION GEL BED, FLAT PRONE GEL BED OPEN HEAD RING GEL, CLOSED HEAD RING GEL, HORSESHOE HEAD RING GEL, OPTHALMIC HEAD REST GEL, PRONE POSITION HEAD REST GEL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2019-02-19
FSE	Table, Operating-Room, Manual	General, Plastic Surgery	Class 1	878.4950	2019-02-19
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2019-02-14
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2019-02-19
IXC	Illuminator, Radiographic-Film	Radiology	Class 1	892.1890	2019-02-19
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2019-02-19
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2019-02-19
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2019-02-19
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2019-02-19
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2019-02-19

Official Correspondent

No official correspondent registered.

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

GALAXY INDIA

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
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015223105. Last updated year: 2026. Please use registration number 3015223105 when referencing this establishment in official correspondence.