Sedecal S A

FDA Filings

This page includes the latest FDA filings for Sedecal S A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1422346
FEI Number1000139935
NameSEDECAL USA, INC.
Owner & OperatorSEDECAL S.A.
Contact AddressPELAYA, 9 POL. POL. IND. "RIO DE JANEIRO"
ALGETE ES-M Madrid, Comunidad de 28110 ES
Official Correspondent
  • MARIA L GOMEZ de AGUERO
  • 34-91-6289055-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address3190 North Kennicott Ave
Arlington Heights, IL 60004 US



Registration Number3006972752
FEI Number3006972752
NameStephanix
Owner & OperatorSEDECAL S.A.
Contact AddressPELAYA, 9 POL. POL. IND. "RIO DE JANEIRO"
ALGETE ES-M Madrid, Comunidad de 28110 ES
Official Correspondent
  • MARIA L GOMEZ de AGUERO
  • 34-91-6289055-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address10 Rue Jean Moulin
La Ricamarie Rhone-Alpes, 42150 FR
Establishment Type
  • Repack or Relabel Medical Device
  • Manufacture Medical Device



Registration Number3011347852
FEI Number3011347852
NameDevan Moser
Owner & OperatorSEDECAL S.A.
Contact AddressPELAYA, 9 POL. POL. IND. "RIO DE JANEIRO"
ALGETE ES-M Madrid, Comunidad de 28110 ES
Official Correspondent
  • MARIA L GOMEZ de AGUERO
  • 34-91-6289055-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3190 North Kennicott Ave
Arlington Heights, IL 60004 US
Establishment TypeManufacture Medical Device



Registration Number1000342169
FEI Number1000342169
NameDevan Moser
Owner & OperatorSEDECAL S.A.
Contact AddressPELAYA, 9 POL. POL. IND. "RIO DE JANEIRO"
ALGETE ES-M Madrid, Comunidad de 28110 ES
Official Correspondent
  • MARIA L GOMEZ de AGUERO
  • 34-91-6289055-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3190 N. Kennicott Ave
Arlington Heights, IL 60004 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number9617251
FEI Number3002495042
NameSEDECAL S.A.
Owner & OperatorSEDECAL S.A.
Contact AddressPELAYA, 9 POL. POL. IND. "RIO DE JANEIRO"
ALGETE ES-M Madrid, Comunidad de 28110 ES
Official Correspondent
  • MARIA L GOMEZ de AGUERO
  • 34-91-6289055-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPELAYA, 9 POL. POL. IND. RIO DE JANEIRO
ALGETE Madrid, Comunidad de, 28110 ES
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number1033419
FEI Number3002539637
NameTINGLE X-RAY LLC
Owner & OperatorSEDECAL S.A.
Contact AddressPELAYA, 9 POL. POL. IND. "RIO DE JANEIRO"
ALGETE ES-M Madrid, Comunidad de 28110 ES
Official Correspondent
  • MARIA L GOMEZ de AGUERO
  • 34-91-6289055-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address5481 SKYLAND BLVD. EAST
Cottondale, AL 35453 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
Sedecal, SA.
Radiographic System Challenge X2020-10-07
SEDECAL S.A.
Soltus 5002019-11-18
SEDECAL S.A.
Soltus 5002019-11-18
Sedecal., SA.
Soltus 5002019-11-15
Devan Moser [SEDECAL S.A.]
Omniscop FP2019-10-21
Devan Moser [SEDECAL S.A.]
OMNISCOP DReam2019-10-21
Devan Moser [SEDECAL S.A.]
ARCO FP2019-10-21
Devan Moser [SEDECAL S.A.]
Omniscop FP2019-10-21
Devan Moser [SEDECAL S.A.]
OMNISCOP DReam2019-10-21
Devan Moser [SEDECAL S.A.]
ARCO FP2019-10-21
Sedecal, SA.
PhoeniX2019-09-25
SEDECAL S.A.
PhoeniX2019-09-25
SEDECAL S.A.
PhoeniX2019-09-25
SEDECAL S.A.
SPSL8HC2019-09-12
SEDECAL S.A.
SPSL4HC2019-09-12
SEDECAL S.A.
SPSL8HC2019-09-12
SEDECAL S.A.
SPSL4HC2019-09-12
Sedecal SA
MobileDiagnost WDR 2.22019-08-02
Devan Moser [SEDECAL S.A.]
Mobilett Elara Max2019-07-02
Devan Moser [SEDECAL S.A.]
Mobilett Mira Max2019-07-02
Devan Moser [SEDECAL S.A.]
Mobilett XP2019-07-02
Sedecal SA
DRAGON X SPSL4HC, DRAGON X SPSL8HC2018-01-26
SEDECAL S.A.
SM-40HF-B-D-VIR2016-08-02
SEDECAL S.A.
SM-40HF-B-D-VIR2016-08-02
SEDECAL SA
RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR2016-07-06
SEDECAL S.A.
MobileDiagnost wDR2016-01-27
SEDECAL S.A.
MobileDiagnost wDR2016-01-27
SEDECAL S.A.
NOVA FA2015-07-03
SEDECAL SA
MOBILEDIAGNOST WDR2014-09-18
SEDECAL SA
NOVA FA DR SYSTEM2014-03-21
SEDECAL S.A.
Definium 50002013-06-17
SEDECAL S.A.
Definium 50002013-06-17
SEDECAL S.A.
SPSL-HF-4.02013-05-06
SEDECAL S.A.
SPSL-HF-4.0-APR2013-05-06
SEDECAL S.A.
SPL-HF-4.02013-05-06
SEDECAL S.A.
SPL-HF-2.02013-05-06
SEDECAL S.A.
SM-50HF-B-D-T2013-05-06
SEDECAL S.A.
SM-50-HF-B-D-KM (AeroDR X30)2013-05-06
SEDECAL S.A.
SM-40HF-B-D-T2013-05-06
SEDECAL S.A.
SM-40-HF-B-D-KM (AeroDR X30)2013-05-06
SEDECAL S.A.
SM-32HF-B-D-T2013-05-06
SEDECAL S.A.
SM-32-HF-B-D-KM (AeroDR X30)2013-05-06
SEDECAL S.A.
SM-20HF-B-D-T2013-05-06
SEDECAL S.A.
SM-20-HF-B-D-KM (AeroDR X30)2013-05-06
SEDECAL S.A.
SM-50HF-B-D-T2013-05-06
SEDECAL S.A.
SM-50-HF-B-D-KM (AeroDR X30)2013-05-06
SEDECAL S.A.
SM-40HF-B-D-T2013-05-06
SEDECAL S.A.
SM-40-HF-B-D-KM (AeroDR X30)2013-05-06
SEDECAL S.A.
SM-32HF-B-D-T2013-05-06
SEDECAL S.A.
SM-32-HF-B-D-KM (AeroDR X30)2013-05-06
SEDECAL S.A.
SM-20HF-B-D-T2013-05-06
SEDECAL S.A.
SM-20-HF-B-D-KM (AeroDR X30)2013-05-06
SEDECAL S.A.
SDRU-T2013-04-23
SEDECAL SA
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T2013-04-18
SEDECAL S.A.
SPSLW82012-08-08
SEDECAL S.A.
SPSLW42012-08-08
SEDECAL S.A.
SPSLW82012-08-08
SEDECAL S.A.
SPSLW42012-08-08
SEDECAL SA
DRAGON LW2012-08-02
SEDECAL S.A.
SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY2011-08-05
SEDECAL S.A.
MobileDiagnost wDR2011-07-26
SEDECAL S.A.
MobileDiagnost wDR2011-07-26
SEDECAL SA
MOBILEDIAGNOST WDR2011-07-19
SEDECAL S.A.
Sedecal X Plus Lp Plus (Digital)2011-05-27
SEDECAL S.A.
SEDECAL2011-01-26
Stephanix [SEDECAL S.A.]
D2RS_AT2010-10-28
Stephanix [SEDECAL S.A.]
D2RS2010-10-28
Stephanix [SEDECAL S.A.]
D2RF2010-10-28
Stephanix [SEDECAL S.A.]
D2RS_AT2010-10-28
Stephanix [SEDECAL S.A.]
D2RS2010-10-28
Stephanix [SEDECAL S.A.]
D2RF2010-10-28
Stephanix [SEDECAL S.A.]
D2RS_AT2010-10-28
Stephanix [SEDECAL S.A.]
D2RS2010-10-28
Stephanix [SEDECAL S.A.]
D2RF2010-10-28
Stephanix [SEDECAL S.A.]
NET41002010-07-29
Stephanix [SEDECAL S.A.]
NET40002010-07-29
Stephanix [SEDECAL S.A.]
FLEXI-DT2010-07-29
Stephanix [SEDECAL S.A.]
D2RS2010-07-29
SEDECAL S.A.
NET41002010-07-29
SEDECAL S.A.
NET40002010-07-29
SEDECAL S.A.
FLEXI-DT2010-07-29
SEDECAL S.A.
D2RS2010-07-29
SEDECAL S.A.
Proteus XR/f AT2010-01-12
SEDECAL S.A.
Millennium Plus2010-01-12
TINGLE X-RAY LLC [SEDECAL S.A.]
SM-50HF-Batt2009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
SM-50HF-B-D-C2009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
SM-40HF-Batt2009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
SM-40HF-B-D-C2009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
SM-32HF-Batt2009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
SM-32HF-B-D-C2009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
SM-20HF-Batt2009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
SM-20HF-B-D-C2009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
Radiologia S.A. Model: Battery Mobile X-Ray Unit TRANSPORTIX B TX-20HF-Batt, TX-32HF-Batt, TX-40HF-Batt, TX-50HF-Batt2009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
Movix 502009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
Movix 50 DReam C2009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
Movix 402009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
Movix 40 DReam C2009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
Movix 302009-05-29
TINGLE X-RAY LLC [SEDECAL S.A.]
Movix 30 DReam C2009-05-29
Stephanix [SEDECAL S.A.]
SM-50HF-Batt2009-05-29
Stephanix [SEDECAL S.A.]
SM-50HF-B-D-C2009-05-29
Stephanix [SEDECAL S.A.]
SM-40HF-Batt2009-05-29
Stephanix [SEDECAL S.A.]
SM-40HF-B-D-C2009-05-29
Stephanix [SEDECAL S.A.]
SM-32HF-Batt2009-05-29
Stephanix [SEDECAL S.A.]
SM-32HF-B-D-C2009-05-29
Stephanix [SEDECAL S.A.]
SM-20HF-Batt2009-05-29
Stephanix [SEDECAL S.A.]
SM-20HF-B-D-C2009-05-29
Stephanix [SEDECAL S.A.]
Radiologia S.A. Model: Battery Mobile X-Ray Unit TRANSPORTIX B TX-20HF-Batt, TX-32HF-Batt, TX-40HF-Batt, TX-50HF-Batt2009-05-29
Stephanix [SEDECAL S.A.]
Movix 502009-05-29
Stephanix [SEDECAL S.A.]
Movix 50 DReam C2009-05-29
Stephanix [SEDECAL S.A.]
Movix 402009-05-29
Stephanix [SEDECAL S.A.]
Movix 40 DReam C2009-05-29
Stephanix [SEDECAL S.A.]
Movix 302009-05-29
Stephanix [SEDECAL S.A.]
Movix 30 DReam C2009-05-29
SEDECAL S.A.
SM-50HF-Batt2009-05-29
SEDECAL S.A.
SM-50HF-B-D-C2009-05-29
SEDECAL S.A.
SM-40HF-Batt2009-05-29
SEDECAL S.A.
SM-40HF-B-D-C2009-05-29
SEDECAL S.A.
SM-32HF-Batt2009-05-29
SEDECAL S.A.
SM-32HF-B-D-C2009-05-29
SEDECAL S.A.
SM-20HF-Batt2009-05-29
SEDECAL S.A.
SM-20HF-B-D-C2009-05-29
SEDECAL S.A.
Radiologia S.A. Model: Battery Mobile X-Ray Unit TRANSPORTIX B TX-20HF-Batt, TX-32HF-Batt, TX-40HF-Batt, TX-50HF-Batt2009-05-29
SEDECAL S.A.
Movix 502009-05-29
SEDECAL S.A.
Movix 50 DReam C2009-05-29
SEDECAL S.A.
Movix 402009-05-29
SEDECAL S.A.
Movix 40 DReam C2009-05-29
SEDECAL S.A.
Movix 302009-05-29
SEDECAL S.A.
Movix 30 DReam C2009-05-29
SEDECAL S.A.
EASY MOVING PLUS, SM-XXHF-YY2009-03-17
SEDECAL S.A.
SEDECAL, MILLENNIUM PLUS2009-03-11
SEDECAL S.A.
SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS2009-02-27
SEDECAL S.A.
Nova System2008-12-12
TINGLE X-RAY LLC [SEDECAL S.A.]
NBS21002008-06-04
SEDECAL S.A.
NBS21002008-06-04
TINGLE X-RAY LLC [SEDECAL S.A.]
STS31002008-02-14
TINGLE X-RAY LLC [SEDECAL S.A.]
Nova2008-02-14
TINGLE X-RAY LLC [SEDECAL S.A.]
Multirad2008-02-14
TINGLE X-RAY LLC [SEDECAL S.A.]
Millennium2008-02-14
SEDECAL S.A.
STS31002008-02-14
SEDECAL S.A.
Nova2008-02-14
SEDECAL S.A.
Multirad2008-02-14
SEDECAL S.A.
Millennium2008-02-14
TINGLE X-RAY LLC [SEDECAL S.A.]
TWBS-TILT2008-02-14
TINGLE X-RAY LLC [SEDECAL S.A.]
MULTIRAD2008-02-14
TINGLE X-RAY LLC [SEDECAL S.A.]
MILLENNIUM2008-02-14
SEDECAL S.A.
TWBS-TILT2008-02-14
SEDECAL S.A.
MULTIRAD2008-02-14
SEDECAL S.A.
MILLENNIUM2008-02-14
SEDECAL S.A.
Sedecal X Plus Lp2007-10-19
SEDECAL S.A.
Sedecal X Plus LP Plus2007-10-19
SEDECAL S.A.
Multi Rad2007-10-19
SEDECAL S.A.
Multi Rad NET2007-10-19
SEDECAL S.A.
Millennium2007-10-19
SEDECAL S.A.
Chiropro2007-10-19
SEDECAL S.A.
Sedecal X Plus Lp2007-10-19
SEDECAL S.A.
Proteus XR/f ST2007-10-19
SEDECAL S.A.
Proteus XR/f ET2007-10-19
SEDECAL S.A.
Multi RAD2007-10-19
SEDECAL S.A.
Millennium2007-10-19
SEDECAL S.A.
FM Floor Mounted Radiographic System2007-10-19
SEDECAL S.A.
Sedecal X Plus Lp2007-10-19
SEDECAL S.A.
Proteus XR/f ST2007-10-19
SEDECAL S.A.
Proteus XR/f ET2007-10-19
SEDECAL S.A.
Multi RAD2007-10-19
SEDECAL S.A.
Millennium2007-10-19
SEDECAL S.A.
FM Floor Mounted Radiographic System2007-10-19
SEDECAL S.A.
URS2007-10-19
SEDECAL S.A.
BRS2007-10-19
SEDECAL S.A.
DEFINIUM 5000 X-RAY SYSTEM2006-11-17
SEDECAL S.A.
SEDECAL X PLUS LP PLUS2006-09-14
SEDECAL S.A.
SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR2004-11-18
SEDECAL S.A.
URS LP DIGITAL, MILLENNIUM, RADPRO2004-11-18
SEDECAL S.A.
PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.02002-02-22
SEDECAL S.A.
NETCP2001-11-29
SEDECAL S.A.
MILLENNIUM2001-11-29
SEDECAL S.A.
SEMER 0022001-11-29
SEDECAL S.A.
SEMER 0012001-11-29
SEDECAL S.A.
Multi Rad2001-11-29
SEDECAL S.A.
MILLENNIUM2001-11-29
SEDECAL S.A.
SHFR100,SHFR300,SHFR400,SHFR500,SHFR600,SHFR8001999-11-30
SEDECAL S.A.
SHF-XXXX-MPSTA1999-11-30
SEDECAL S.A.
SHF-XXXX-M1999-11-30
SEDECAL S.A.
SHF-XXXX-C Series1999-11-30
SEDECAL S.A.
SHF-XXXX Series1999-11-30
SEDECAL S.A.
SHF-XXXX PSU Series1999-11-30
SEDECAL S.A.
SHF-XXX-C Series1999-11-30
SEDECAL S.A.
SHF-XXX Series1999-11-30
SEDECAL S.A.
SHF-XXX PSU Series1999-11-30
SEDECAL S.A.
HERCULES-XX1999-11-30

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