Swissray I N T Inc

FDA Filings

This page includes the latest FDA filings for Swissray I N T Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Swissray I N T Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3031197
FEI Number3000718029
NameSWISSRAY INTERNATIONAL INC.
Owner & OperatorSwissray International, Inc.
Contact Address1090 King Georges Post Road Unit 1203
Edison NJ 08837 US
Official Correspondent
  • Deniz K Kortan
  • 01-908-3726408-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1090 King Georges Post Road Unit 1203
Edison, NJ 08837 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Repack or Relabel Medical Device

Registration Number9614430
FEI Number3002143662
NameSWISSRAY Medical, AG
Owner & OperatorSwissray International, Inc.
Contact Address1090 King Georges Post Road Unit 1203
Edison NJ 08837 US
Official Correspondent
  • Deniz K Kortan
  • 01-908-3726408-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressTURBISTRASSE 25-27
HOCHDORF Luzern, CH 6280 CH
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

Registration Number2124648
FEI Number2124648
NameNORLAND at SWISSRAY
Owner & OperatorSwissray International, Inc.
Contact Address1090 King Georges Post Road Unit 1203
Edison NJ 08837 US
Official Correspondent
  • Deniz K Kortan
  • 01-908-3726408-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressW6340 Hackbarth Rd
FORT ATKINSON, WI 53538 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
SWISSRAY Medical, AG [Swissray International, Inc.]
SR Pulse 7102017-04-21
SWISSRAY INTERNATIONAL INC. [Swissray International, Inc.]
SR Pulse 7102017-04-21
SWISSRAY Medical, AG [Swissray International, Inc.]
ddrAura (TM) Series2016-04-07
SWISSRAY INTERNATIONAL INC. [Swissray International, Inc.]
ddrAura (TM) Series2016-04-07
NORLAND at SWISSRAY [Swissray International, Inc.]
Norland, McCue CUBA Clinical Ultrasonic Bone Sonometry System2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
Norland, Apollo Multi Radical Reference Population2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
XR 800 DXA Bone Densitometer2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
XR 600 DXA Bone Densitometer2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
XR 46 DXA Bone Densitometer2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
ELITE DXA Bone Densitometer2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
Norland, Fracture Risk Analysis2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
Norland, Body Composition Option2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
Norland Apollo Bone Densitometer2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
pDEXA Bone Densitometer2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
Norland, Forearm Scan Option2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
Norland, Lateral Spine Option2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
Norland, Whole Body Scan Option2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
Ten Year Fracture Risk2014-01-16
NORLAND at SWISSRAY [Swissray International, Inc.]
SIRI Table Option for Norland DXA Bone Densitometer2014-01-16
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCruze2013-07-02
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCruze Plus2013-07-02
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCruze2013-07-02
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCruze Plus2013-07-02
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRElement2012-10-22
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRElement2012-10-22
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCompact2008-03-25
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCompact Plus2008-03-25
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCompact Chest2008-03-25
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRFormula2008-03-25
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRFormula Plus2008-03-25
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCombi Trauma2008-03-25
SWISSRAY Medical, AG [Swissray International, Inc.]
ddRCombi Plus2008-03-25
SWISSRAY INTERNATIONAL, INC.
DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST2007-05-02
SWISSRAY INTERNATIONAL, INC.
DDRCOMBI TRAUMA2005-05-26
SWISSRAY INTERNATIONAL, INC.
DIGITAL ADD ON MULTI SYSTEM1997-12-18

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE Code35YU8SWISSRAY INTERNATIONAL, INC.
NCAGE Code3LXV5SWISSRAY INTERNATIONAL INC
CAGE Code35YU8SWISSRAY INTERNATIONAL, INC.
CAGE Code3LXV5SWISSRAY INTERNATIONAL, INC SWISSRAY INTERNATIONAL, INC
DUNS002529191SWISSRAY INTERNATIONAL, INC
DUNS002529191SWISSRAY INTERNATIONAL, INC
SEC0001002137SWISSRAY INTERNATIONAL INC of NEW YORK
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