Stephanix

FDA Filings

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

FDA Registration(s)
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



FDA Filings

Device
Company
DeviceDate
Stephanix
MOVIX DReamy2021-11-03
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
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

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NCAGE CodeFAML2STEPHANIX
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