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.
Registration Number | 1422346 |
FEI Number | 1000139935 |
Name | SEDECAL USA, INC. |
Owner & Operator | SEDECAL S.A. |
Contact Address | PELAYA, 9 POL. POL. IND. "RIO DE JANEIRO" ALGETE ES-M Madrid, Comunidad de 28110 ES |
Official Correspondent |
|
Registration Status | 1 |
Initial Importer | Y |
Registration Expiration | 2020-04-25 |
Registration Address | 3190 North Kennicott Ave Arlington Heights, IL 60004 US |
Registration Number | 3006972752 |
FEI Number | 3006972752 |
Name | Stephanix |
Owner & Operator | SEDECAL S.A. |
Contact Address | PELAYA, 9 POL. POL. IND. "RIO DE JANEIRO" ALGETE ES-M Madrid, Comunidad de 28110 ES |
Official Correspondent |
|
US Agent |
|
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | 10 Rue Jean Moulin La Ricamarie Rhone-Alpes, 42150 FR |
Establishment Type |
|
Registration Number | 3011347852 |
FEI Number | 3011347852 |
Name | Devan Moser |
Owner & Operator | SEDECAL S.A. |
Contact Address | PELAYA, 9 POL. POL. IND. "RIO DE JANEIRO" ALGETE ES-M Madrid, Comunidad de 28110 ES |
Official Correspondent |
|
US Agent |
|
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | 3190 North Kennicott Ave Arlington Heights, IL 60004 US |
Establishment Type | Manufacture Medical Device |
Registration Number | 1000342169 |
FEI Number | 1000342169 |
Name | Devan Moser |
Owner & Operator | SEDECAL S.A. |
Contact Address | PELAYA, 9 POL. POL. IND. "RIO DE JANEIRO" ALGETE ES-M Madrid, Comunidad de 28110 ES |
Official Correspondent |
|
US Agent |
|
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | 3190 N. Kennicott Ave Arlington Heights, IL 60004 US |
Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
Registration Number | 9617251 |
FEI Number | 3002495042 |
Name | SEDECAL S.A. |
Owner & Operator | SEDECAL S.A. |
Contact Address | PELAYA, 9 POL. POL. IND. "RIO DE JANEIRO" ALGETE ES-M Madrid, Comunidad de 28110 ES |
Official Correspondent |
|
US Agent |
|
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | PELAYA, 9 POL. POL. IND. RIO DE JANEIRO ALGETE Madrid, Comunidad de, 28110 ES |
Establishment Type |
|
Registration Number | 1033419 |
FEI Number | 3002539637 |
Name | TINGLE X-RAY LLC |
Owner & Operator | SEDECAL S.A. |
Contact Address | PELAYA, 9 POL. POL. IND. "RIO DE JANEIRO" ALGETE ES-M Madrid, Comunidad de 28110 ES |
Official Correspondent |
|
Registration Status | 1 |
Initial Importer | Y |
Registration Expiration | 2020-04-25 |
Registration Address | 5481 SKYLAND BLVD. EAST Cottondale, AL 35453 US |
Establishment Type |
|
Device Company | Device | Date |
---|---|---|
SEDECAL SA | PHOENIX/AeroDR TX M01 And PHOENIX/mKDR Xpress. | 2022-07-18 |
SEDECAL SA | Proteus XR/f, Models ST And ET, Multirad And Multirad NET Radiographic Systems | 2021-02-01 |
Sedecal, SA. | Radiographic System Challenge X | 2020-10-07 |
SEDECAL S.A. | Soltus 500 | 2019-11-18 |
SEDECAL S.A. | Soltus 500 | 2019-11-18 |
Sedecal., SA. | Soltus 500 | 2019-11-15 |
Devan Moser [SEDECAL S.A.] | Omniscop FP | 2019-10-21 |
Devan Moser [SEDECAL S.A.] | OMNISCOP DReam | 2019-10-21 |
Devan Moser [SEDECAL S.A.] | ARCO FP | 2019-10-21 |
Devan Moser [SEDECAL S.A.] | Omniscop FP | 2019-10-21 |
Devan Moser [SEDECAL S.A.] | OMNISCOP DReam | 2019-10-21 |
Devan Moser [SEDECAL S.A.] | ARCO FP | 2019-10-21 |
Sedecal, SA. | PhoeniX | 2019-09-25 |
SEDECAL S.A. | PhoeniX | 2019-09-25 |
SEDECAL S.A. | PhoeniX | 2019-09-25 |
SEDECAL S.A. | SPSL8HC | 2019-09-12 |
SEDECAL S.A. | SPSL4HC | 2019-09-12 |
SEDECAL S.A. | SPSL8HC | 2019-09-12 |
SEDECAL S.A. | SPSL4HC | 2019-09-12 |
Sedecal SA | MobileDiagnost WDR 2.2 | 2019-08-02 |
Devan Moser [SEDECAL S.A.] | Mobilett Elara Max | 2019-07-02 |
Devan Moser [SEDECAL S.A.] | Mobilett Mira Max | 2019-07-02 |
Devan Moser [SEDECAL S.A.] | Mobilett XP | 2019-07-02 |
Sedecal SA | DRAGON X SPSL4HC, DRAGON X SPSL8HC | 2018-01-26 |
SEDECAL S.A. | SM-40HF-B-D-VIR | 2016-08-02 |
SEDECAL S.A. | SM-40HF-B-D-VIR | 2016-08-02 |
SEDECAL SA | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR | 2016-07-06 |
SEDECAL S.A. | MobileDiagnost wDR | 2016-01-27 |
SEDECAL S.A. | MobileDiagnost wDR | 2016-01-27 |
SEDECAL S.A. | NOVA FA | 2015-07-03 |
SEDECAL SA | MOBILEDIAGNOST WDR | 2014-09-18 |
SEDECAL SA | NOVA FA DR SYSTEM | 2014-03-21 |
SEDECAL S.A. | Definium 5000 | 2013-06-17 |
SEDECAL S.A. | Definium 5000 | 2013-06-17 |
SEDECAL S.A. | SPSL-HF-4.0 | 2013-05-06 |
SEDECAL S.A. | SPSL-HF-4.0-APR | 2013-05-06 |
SEDECAL S.A. | SPL-HF-4.0 | 2013-05-06 |
SEDECAL S.A. | SPL-HF-2.0 | 2013-05-06 |
SEDECAL S.A. | SM-50HF-B-D-T | 2013-05-06 |
SEDECAL S.A. | SM-50-HF-B-D-KM (AeroDR X30) | 2013-05-06 |
SEDECAL S.A. | SM-40HF-B-D-T | 2013-05-06 |
SEDECAL S.A. | SM-40-HF-B-D-KM (AeroDR X30) | 2013-05-06 |
SEDECAL S.A. | SM-32HF-B-D-T | 2013-05-06 |
SEDECAL S.A. | SM-32-HF-B-D-KM (AeroDR X30) | 2013-05-06 |
SEDECAL S.A. | SM-20HF-B-D-T | 2013-05-06 |
SEDECAL S.A. | SM-20-HF-B-D-KM (AeroDR X30) | 2013-05-06 |
SEDECAL S.A. | SM-50HF-B-D-T | 2013-05-06 |
SEDECAL S.A. | SM-50-HF-B-D-KM (AeroDR X30) | 2013-05-06 |
SEDECAL S.A. | SM-40HF-B-D-T | 2013-05-06 |
SEDECAL S.A. | SM-40-HF-B-D-KM (AeroDR X30) | 2013-05-06 |
SEDECAL S.A. | SM-32HF-B-D-T | 2013-05-06 |
SEDECAL S.A. | SM-32-HF-B-D-KM (AeroDR X30) | 2013-05-06 |
SEDECAL S.A. | SM-20HF-B-D-T | 2013-05-06 |
SEDECAL S.A. | SM-20-HF-B-D-KM (AeroDR X30) | 2013-05-06 |
SEDECAL S.A. | SDRU-T | 2013-04-23 |
SEDECAL SA | SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T | 2013-04-18 |
SEDECAL S.A. | SPSLW8 | 2012-08-08 |
SEDECAL S.A. | SPSLW4 | 2012-08-08 |
SEDECAL S.A. | SPSLW8 | 2012-08-08 |
SEDECAL S.A. | SPSLW4 | 2012-08-08 |
SEDECAL SA | DRAGON LW | 2012-08-02 |
SEDECAL S.A. | SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY | 2011-08-05 |
SEDECAL S.A. | MobileDiagnost wDR | 2011-07-26 |
SEDECAL S.A. | MobileDiagnost wDR | 2011-07-26 |
SEDECAL SA | MOBILEDIAGNOST WDR | 2011-07-19 |
SEDECAL S.A. | Sedecal X Plus Lp Plus (Digital) | 2011-05-27 |
SEDECAL S.A. | SEDECAL | 2011-01-26 |
Stephanix [SEDECAL S.A.] | D2RS_AT | 2010-10-28 |
Stephanix [SEDECAL S.A.] | D2RS | 2010-10-28 |
Stephanix [SEDECAL S.A.] | D2RF | 2010-10-28 |
Stephanix [SEDECAL S.A.] | D2RS_AT | 2010-10-28 |
Stephanix [SEDECAL S.A.] | D2RS | 2010-10-28 |
Stephanix [SEDECAL S.A.] | D2RF | 2010-10-28 |
Stephanix [SEDECAL S.A.] | D2RS_AT | 2010-10-28 |
Stephanix [SEDECAL S.A.] | D2RS | 2010-10-28 |
Stephanix [SEDECAL S.A.] | D2RF | 2010-10-28 |
Stephanix [SEDECAL S.A.] | NET4100 | 2010-07-29 |
Stephanix [SEDECAL S.A.] | NET4000 | 2010-07-29 |
Stephanix [SEDECAL S.A.] | FLEXI-DT | 2010-07-29 |
Stephanix [SEDECAL S.A.] | D2RS | 2010-07-29 |
SEDECAL S.A. | NET4100 | 2010-07-29 |
SEDECAL S.A. | NET4000 | 2010-07-29 |
SEDECAL S.A. | FLEXI-DT | 2010-07-29 |
SEDECAL S.A. | D2RS | 2010-07-29 |
SEDECAL S.A. | Proteus XR/f AT | 2010-01-12 |
SEDECAL S.A. | Millennium Plus | 2010-01-12 |
TINGLE X-RAY LLC [SEDECAL S.A.] | SM-50HF-Batt | 2009-05-29 |
TINGLE X-RAY LLC [SEDECAL S.A.] | SM-50HF-B-D-C | 2009-05-29 |
TINGLE X-RAY LLC [SEDECAL S.A.] | SM-40HF-Batt | 2009-05-29 |
TINGLE X-RAY LLC [SEDECAL S.A.] | SM-40HF-B-D-C | 2009-05-29 |
TINGLE X-RAY LLC [SEDECAL S.A.] | SM-32HF-Batt | 2009-05-29 |
TINGLE X-RAY LLC [SEDECAL S.A.] | SM-32HF-B-D-C | 2009-05-29 |
TINGLE X-RAY LLC [SEDECAL S.A.] | SM-20HF-Batt | 2009-05-29 |
TINGLE X-RAY LLC [SEDECAL S.A.] | SM-20HF-B-D-C | 2009-05-29 |
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-Batt | 2009-05-29 |
TINGLE X-RAY LLC [SEDECAL S.A.] | Movix 50 | 2009-05-29 |
TINGLE X-RAY LLC [SEDECAL S.A.] | Movix 50 DReam C | 2009-05-29 |
TINGLE X-RAY LLC [SEDECAL S.A.] | Movix 40 | 2009-05-29 |
TINGLE X-RAY LLC [SEDECAL S.A.] | Movix 40 DReam C | 2009-05-29 |
TINGLE X-RAY LLC [SEDECAL S.A.] | Movix 30 | 2009-05-29 |
TINGLE X-RAY LLC [SEDECAL S.A.] | Movix 30 DReam C | 2009-05-29 |
Stephanix [SEDECAL S.A.] | SM-50HF-Batt | 2009-05-29 |
Stephanix [SEDECAL S.A.] | SM-50HF-B-D-C | 2009-05-29 |
Stephanix [SEDECAL S.A.] | SM-40HF-Batt | 2009-05-29 |
Stephanix [SEDECAL S.A.] | SM-40HF-B-D-C | 2009-05-29 |
Stephanix [SEDECAL S.A.] | SM-32HF-Batt | 2009-05-29 |
Stephanix [SEDECAL S.A.] | SM-32HF-B-D-C | 2009-05-29 |
Stephanix [SEDECAL S.A.] | SM-20HF-Batt | 2009-05-29 |
Stephanix [SEDECAL S.A.] | SM-20HF-B-D-C | 2009-05-29 |
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-Batt | 2009-05-29 |
Stephanix [SEDECAL S.A.] | Movix 50 | 2009-05-29 |
Stephanix [SEDECAL S.A.] | Movix 50 DReam C | 2009-05-29 |
Stephanix [SEDECAL S.A.] | Movix 40 | 2009-05-29 |
Stephanix [SEDECAL S.A.] | Movix 40 DReam C | 2009-05-29 |
Stephanix [SEDECAL S.A.] | Movix 30 | 2009-05-29 |
Stephanix [SEDECAL S.A.] | Movix 30 DReam C | 2009-05-29 |
SEDECAL S.A. | SM-50HF-Batt | 2009-05-29 |
SEDECAL S.A. | SM-50HF-B-D-C | 2009-05-29 |
SEDECAL S.A. | SM-40HF-Batt | 2009-05-29 |
SEDECAL S.A. | SM-40HF-B-D-C | 2009-05-29 |
SEDECAL S.A. | SM-32HF-Batt | 2009-05-29 |
SEDECAL S.A. | SM-32HF-B-D-C | 2009-05-29 |
SEDECAL S.A. | SM-20HF-Batt | 2009-05-29 |
SEDECAL S.A. | SM-20HF-B-D-C | 2009-05-29 |
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-Batt | 2009-05-29 |
SEDECAL S.A. | Movix 50 | 2009-05-29 |
SEDECAL S.A. | Movix 50 DReam C | 2009-05-29 |
SEDECAL S.A. | Movix 40 | 2009-05-29 |
SEDECAL S.A. | Movix 40 DReam C | 2009-05-29 |
SEDECAL S.A. | Movix 30 | 2009-05-29 |
SEDECAL S.A. | Movix 30 DReam C | 2009-05-29 |
SEDECAL S.A. | EASY MOVING PLUS, SM-XXHF-YY | 2009-03-17 |
SEDECAL S.A. | SEDECAL, MILLENNIUM PLUS | 2009-03-11 |
SEDECAL S.A. | SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS | 2009-02-27 |
SEDECAL S.A. | Nova System | 2008-12-12 |
TINGLE X-RAY LLC [SEDECAL S.A.] | NBS2100 | 2008-06-04 |
SEDECAL S.A. | NBS2100 | 2008-06-04 |
TINGLE X-RAY LLC [SEDECAL S.A.] | STS3100 | 2008-02-14 |
TINGLE X-RAY LLC [SEDECAL S.A.] | Nova | 2008-02-14 |
TINGLE X-RAY LLC [SEDECAL S.A.] | Multirad | 2008-02-14 |
TINGLE X-RAY LLC [SEDECAL S.A.] | Millennium | 2008-02-14 |
SEDECAL S.A. | STS3100 | 2008-02-14 |
SEDECAL S.A. | Nova | 2008-02-14 |
SEDECAL S.A. | Multirad | 2008-02-14 |
SEDECAL S.A. | Millennium | 2008-02-14 |
TINGLE X-RAY LLC [SEDECAL S.A.] | TWBS-TILT | 2008-02-14 |
TINGLE X-RAY LLC [SEDECAL S.A.] | MULTIRAD | 2008-02-14 |
TINGLE X-RAY LLC [SEDECAL S.A.] | MILLENNIUM | 2008-02-14 |
SEDECAL S.A. | TWBS-TILT | 2008-02-14 |
SEDECAL S.A. | MULTIRAD | 2008-02-14 |
SEDECAL S.A. | MILLENNIUM | 2008-02-14 |
SEDECAL S.A. | Sedecal X Plus Lp | 2007-10-19 |
SEDECAL S.A. | Sedecal X Plus LP Plus | 2007-10-19 |
SEDECAL S.A. | Multi Rad | 2007-10-19 |
SEDECAL S.A. | Multi Rad NET | 2007-10-19 |
SEDECAL S.A. | Millennium | 2007-10-19 |
SEDECAL S.A. | Chiropro | 2007-10-19 |
SEDECAL S.A. | Sedecal X Plus Lp | 2007-10-19 |
SEDECAL S.A. | Proteus XR/f ST | 2007-10-19 |
SEDECAL S.A. | Proteus XR/f ET | 2007-10-19 |
SEDECAL S.A. | Multi RAD | 2007-10-19 |
SEDECAL S.A. | Millennium | 2007-10-19 |
SEDECAL S.A. | FM Floor Mounted Radiographic System | 2007-10-19 |
SEDECAL S.A. | Sedecal X Plus Lp | 2007-10-19 |
SEDECAL S.A. | Proteus XR/f ST | 2007-10-19 |
SEDECAL S.A. | Proteus XR/f ET | 2007-10-19 |
SEDECAL S.A. | Multi RAD | 2007-10-19 |
SEDECAL S.A. | Millennium | 2007-10-19 |
SEDECAL S.A. | FM Floor Mounted Radiographic System | 2007-10-19 |
SEDECAL S.A. | URS | 2007-10-19 |
SEDECAL S.A. | BRS | 2007-10-19 |
SEDECAL S.A. | DEFINIUM 5000 X-RAY SYSTEM | 2006-11-17 |
SEDECAL S.A. | SEDECAL X PLUS LP PLUS | 2006-09-14 |
SEDECAL S.A. | SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR | 2004-11-18 |
SEDECAL S.A. | URS LP DIGITAL, MILLENNIUM, RADPRO | 2004-11-18 |
SEDECAL S.A. | PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 | 2002-02-22 |
SEDECAL S.A. | NETCP | 2001-11-29 |
SEDECAL S.A. | MILLENNIUM | 2001-11-29 |
SEDECAL S.A. | SEMER 002 | 2001-11-29 |
SEDECAL S.A. | SEMER 001 | 2001-11-29 |
SEDECAL S.A. | Multi Rad | 2001-11-29 |
SEDECAL S.A. | MILLENNIUM | 2001-11-29 |
SEDECAL S.A. | SHFR100,SHFR300,SHFR400,SHFR500,SHFR600,SHFR800 | 1999-11-30 |
SEDECAL S.A. | SHF-XXXX-MPSTA | 1999-11-30 |
SEDECAL S.A. | SHF-XXXX-M | 1999-11-30 |
SEDECAL S.A. | SHF-XXXX-C Series | 1999-11-30 |
SEDECAL S.A. | SHF-XXXX Series | 1999-11-30 |
SEDECAL S.A. | SHF-XXXX PSU Series | 1999-11-30 |
SEDECAL S.A. | SHF-XXX-C Series | 1999-11-30 |
SEDECAL S.A. | SHF-XXX Series | 1999-11-30 |
SEDECAL S.A. | SHF-XXX PSU Series | 1999-11-30 |
SEDECAL S.A. | HERCULES-XX | 1999-11-30 |
Import ID | Shipment | Cargo Description | Quantity |
---|---|---|---|
2020090349310 | Barcelona ,Spain -> Miami, Florida | MOBILE RADIOGRAPHIC SYSTEM HS CODE 9022140000 | 1 PKG |
2020090349309 | Barcelona ,Spain -> Miami, Florida | MOBILE RADIOGRAPHIC SYSTEM HS 9022140000 | 2 PKG |
2020090239494 | Barcelona ,Spain -> Miami, Florida | MOBILE RADIOGRAPHIC SYSTEM HS 9022140000 | 2 PKG |
2020090239495 | Barcelona ,Spain -> Miami, Florida | MOBILE RADIOGRAPHIC SYSTEM HS CODE 9022140000 | 1 PKG |
2020082856897 | Valencia,Spain -> Norfolk, Virginia | MEDICAL EQUIPMENT,FLOOR MOUNTED TUBESTAND MIL LENIUM | 42 PKG |
2020082638667 | Barcelona ,Spain -> Miami, Florida | XRAY SPARE PARTS HS CODE 9022140000 | 2 PKG |
2020081518612 | Valencia,Spain -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENT | 3 PKG |
2020081518643 | Valencia,Spain -> New York, New York | MEDICAL EQUIPMENT | 3 PKG |