Philips India L T D

FDA Filings

This page includes the latest FDA filings for Philips India L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010685285
FEI Number3010685285
NamePhilips India Limited
Owner & OperatorPhilips Medical Systems International BV
Contact AddressTussendiepen 4
Drachten NL-NOTA 9206 AD NL
US Agent
Importing Logistics Registration
ImporterDHL Express
Address1210 Pine Island Rd
Plantation, FL 33324 UNITED STATES
Importer TypeAgent
Importing Logistics Registration
ImporterExpeditors International of Washington Inc
Address1015 Third Ave 12th Floor
Seattle, WA 98104 UNITED STATES
Importer TypeAgent
Importing Logistics Registration
ImporterFedEx Trade Networks
Address3800 Forest Hill-Irene Road
Hickory Hill, TN 38125 UNITED STATES
Importer TypeBroker
Importing Logistics Registration
ImporterPanalpina
Address67 Park Place
Morristown, NJ 07960 UNITED STATES
Importer TypeAgent
Importing Logistics Registration
ImporterUPS Supply Chain Solutions
Address12380 Morris Road
Alpharetta, GA 30005 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPlot no. B-79, MIDC, Phase-II, Chakan Taluka - khed, Village - Savardari
Pune Maharashtra, 410 501 IN
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device
Company
DeviceDate
Philips India Limited
 StentBoost 7181602021-06-23
Philips India Limited
StentBoost Mobile2021-04-05
Philips India Limited [Philips Medical Systems International BV]
Zenition 502019-03-27
Philips India Limited [Philips Medical Systems International BV]
Zenition 502019-03-27
Philips India Limited [Philips Medical Systems International BV]
Zenition 502019-03-27
Philips India Limited [Philips Medical Systems International BV]
Zenition 702019-03-27
Philips India Limited [Philips Medical Systems International BV]
Zenition 702019-03-27
Philips India Limited [Philips Medical Systems International BV]
Zenition 702019-03-27
Philips India Limited [Philips Medical Systems International BV]
Square Collimator FD152019-03-27
Philips India Limited [Philips Medical Systems International BV]
Square Collimator FD122019-03-27
Philips India Limited [Philips Medical Systems International BV]
Collimator IITV2019-03-27
Philips India Limited
MobileDiagnost M502017-11-16
Philips India Limited [Philips Medical Systems International BV]
MicroDose SI2015-05-26
Philips India Limited [Philips Medical Systems International BV]
MicroDose SI2015-05-26
Philips India Limited [Philips Medical Systems International BV]
L302015-03-12
Philips India Limited [Philips Medical Systems International BV]
Veradius Unity2014-10-31
Philips India Limited [Philips Medical Systems International BV]
Veradius Unity2014-10-31
Philips India Limited [Philips Medical Systems International BV]
Veradius Unity2014-10-31
Philips India Limited [Philips Medical Systems International BV]
MicroDose SI (model L50)2013-04-30
Philips India Limited [Philips Medical Systems International BV]
IntelliSpace PACS 4.X2011-08-09
Philips India Limited [Philips Medical Systems International BV]
IntelliSpace Breast2011-08-09
Philips India Limited [Philips Medical Systems International BV]
MammoDiagnost VU2009-09-03
Philips India Limited [Philips Medical Systems International BV]
NICOL Collimator Family2006-02-21
Philips India Limited [Philips Medical Systems International BV]
BV Pulsera - 7180952006-02-21
Philips India Limited [Philips Medical Systems International BV]
BV Endura2006-02-21
Philips India Limited [Philips Medical Systems International BV]
BV Pulsera - 7180952006-02-21
Philips India Limited [Philips Medical Systems International BV]
BV Endura2006-02-21
Philips India Limited [Philips Medical Systems International BV]
BV Pulsera - 7180952006-02-21
Philips India Limited [Philips Medical Systems International BV]
BV Endura2006-02-21
Philips India Limited [Philips Medical Systems International BV]
XS-100 Generator2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Velara2006-02-21
Philips India Limited [Philips Medical Systems International BV]
IXION III HF GENERATOR2006-02-21
Philips India Limited [Philips Medical Systems International BV]
HF GENERATOR IV 15KW2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Generator high voltage2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Certeray2006-02-21
Philips India Limited [Philips Medical Systems International BV]
CT XS Generator2006-02-21
Philips India Limited [Philips Medical Systems International BV]
XS-100 X-ray tube assembly2006-02-21
Philips India Limited [Philips Medical Systems International BV]
X-ray Tube MX2402006-02-21
Philips India Limited [Philips Medical Systems International BV]
THA Straton Z x-ray Tube2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Sxxx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Straton MX X-Ray tube cpl2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Sapphire Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
SROxxx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
SRO (Super Rotalix)2006-02-21
Philips India Limited [Philips Medical Systems International BV]
SRM (Super Rotalix Metal)2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Reevo 240G2006-02-21
Philips India Limited [Philips Medical Systems International BV]
ROTxxx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
RO (Rotalix)2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Powerphos VP2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Philips MRC2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Persus Performix HD2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Performix 160a2006-02-21
Philips India Limited [Philips Medical Systems International BV]
PX15xx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
PX14xx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
PX13xx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Monoblock IXION V2006-02-21
Philips India Limited [Philips Medical Systems International BV]
MXxxx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
MX2002006-02-21
Philips India Limited [Philips Medical Systems International BV]
MRM (Maximus Rotalix Metal)2006-02-21
Philips India Limited [Philips Medical Systems International BV]
MRC200 0407 GS10042006-02-21
Philips India Limited [Philips Medical Systems International BV]
MRC 880 X-ray tube2006-02-21
Philips India Limited [Philips Medical Systems International BV]
MRC 800 X-ray tube2006-02-21
Philips India Limited [Philips Medical Systems International BV]
MRC 600 X-ray tube2006-02-21
Philips India Limited [Philips Medical Systems International BV]
MRC 200 0508 ROT-GS 10032006-02-21
Philips India Limited [Philips Medical Systems International BV]
MRC 200 0407 ROT GS 10042006-02-21
Philips India Limited [Philips Medical Systems International BV]
MRC (Maximus Rotalix Ceramic)2006-02-21
Philips India Limited [Philips Medical Systems International BV]
MEGALIX Cat 125/15/40/80-122 GW2006-02-21
Philips India Limited [Philips Medical Systems International BV]
IXION MONOBLOCK2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Exxx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Emerald Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Dynamax Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Dura 4222006-02-21
Philips India Limited [Philips Medical Systems International BV]
Diamond Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
DUxxx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
DUNLEE CONSTANT POTENTIAL GENERATOR2006-02-21
Philips India Limited [Philips Medical Systems International BV]
DU, DR2006-02-21
Philips India Limited [Philips Medical Systems International BV]
DRxxx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
DAxxx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
CTTxx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
CTR22xx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
CTR21xx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
CTR17xx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
CTR15xx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
CT XS Tube2006-02-21
Philips India Limited [Philips Medical Systems International BV]
Bxxx Series2006-02-21
Philips India Limited [Philips Medical Systems International BV]
AMXxx Series2006-02-21

Related Finance Registrations
NCAGE Code1PCQYPHILIPS INDIA LTD.
NCAGE Code1L1XYPHILIPS INDIA LTD
NCAGE Code1FFHYPHILIPS INDIA LTD
NCAGE Code1DEXYPHILIPS INDIA LTD.
NCAGE Code1CVEYPHILIPS INDIA LTD.
NCAGE Code0054YPHILIPS INDIA LTD
NCAGE CodeS4337PHILIPS INDIA LTD
CAGE CodeS4337PHILIPS INDIA LTD
CAGE Code1PCQYPHILIPS INDIA LTD.
CAGE Code1L1XYPHILIPS INDIA LIMITED
CAGE Code1FFHYPHILIPS INDIA LTD
CAGE Code1DEXYPHILIPS INDIA LTD.
CAGE Code1CVEYPHILIPS INDIA LTD.
CAGE Code0054YPHILIPS INDIA LTD
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
20191221884Colombo Harbor,Sri Lanka -> New York/Newark Area, Newark, New JerseyMAGNETWA3.0T SN WF 3000603 MAGNETF2000MEU1.5 TSNTL 150 4075 MAGNETF2000MEU1.5T SN TR 150 5189 INV.NO CSCHN427 DT.16.10.2019 SB.NO 782 4187 DT.24.10.2019 NT.WT 9000.000 KGS FREIGHT PREPAID ATTENTION BOB BOWMAN CASE NO3 PKG
2019112621858Colombo Harbor,Sri Lanka -> New York/Newark Area, Newark, New JerseyMAGNETWA3.0T SN WF 3000603 MAGNETF2000MEU1.5 TSNTL 150 4075 MAGNETF2000MEU1.5T SN TR 150 5189 INV.NO CSCHN427 DT.16.10.2019 SB.NO 782 4187 DT.24.10.2019 NT.WT 9000.000 KGS FREIGHT PREPAID ATTENTION BOB BOWMAN CASE NO3 PKG
2019083155760Algeciras,Spain -> Miami, FloridaMEDICAL EQUIPMENT C-ARM IMAGE INTENSIFIER SYSTEM BV VECTRA PART NO. 718400 SR. NO. 1033 , 1034 INV NO. 2018001305, 20 18001306 DT.22.07.2019 ORDER NO: 4513945467, 4513945468 TO TAL QTY: 2 SET TOTAL NET WEIG4 PKG
2019071724722Nhava Sheva,India -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT - MEDICAL EQUIPMENT BV VECT R A PART NO. 718400 SR.NO.99 7 ORDER NO. 4513 580540 TOT AL QTY: 1 SET S/BILL NO.46 37616 D T 03.06.2019 HS COD E: 90221490 =CONTACT: PAT R ICIA.VALLE=PHILIPS.COM PHO NE +52 1 55 5403 9481 ==PH ONE: (+229) 931- 5346, 932 -55- 45 /931-35-302 BOX
2019071627466Colombo Harbor,Sri Lanka -> New York/Newark Area, Newark, New JerseyMAGNETF2000MEU1.5T TR1505192 MAGNETF2000MEU1. 5T TN150 4525 INV.NO CSCHN042 DT.14.06.2019 CSCHN043 DT.14.06.2019 IEC NO 388013567 HSN C ODE 90181300. SB.NO 4877901 DT.14.06.2019 FR EIGHT PREPAID2 PKG
2018112056436Algeciras,Spain -> Port Everglades, FloridaMEDICAL EQUIPMENT C-ARM IMAGE INTENSIFIER SYSTEM BV VECTRA PART NO. 718400 SR. NO. 852 INV NO. 90366644 DT.16.08.20 18 ORDER NO: 4512857462, 4512 857464 TOTAL QTY: 2 SET TOTA L NET WEIGHT: 1006.000 KGS S/4 BOX
2018092168225Algeciras,Spain -> Port Everglades, FloridaMEDICAL EQUIPMENT CARDIO & VA SCULAR ANGIOGRAPHY SYSTEMS IN CLUDING DIGITAL SUBSTRACTION A NGIOGRAPHY PART NO. 723005 S R. NO. 85 INV NO. 90366644 D T.16.08.2018 ORDER NO: 451253 5006 TOTAL QTY: 1 SET TOTAL9 BOX
2018091822496Colombo Harbor,Sri Lanka -> New York/Newark Area, Newark, New JerseyMAGNETF2000D1.5T 4K SERIAL NO VA1500148 PAR T NO989603028231 MAGNETF2000MEU1.5T SERIAL NO VA1500148 PART NO989603019702 INV.NO 45116 49846 DT.27.06.2018 INV.NO 4512502526 DT.27. 06.2018 IEC NO 388013567 HSN CODE 90181300. S B.2 PKG
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