Somatex Medical Technologies G M B H

FDA Filings

This page includes the latest FDA filings for Somatex Medical Technologies G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1000408433
FEI Number1000408433
NameSomatex Medical Technologies GmbH
Owner & OperatorSOMATEX MEDICAL TECHNOLOGIES GMBH
Contact AddressHohenzollerndamm 150-151 --
Berlin DE-BE Berlin 14199 DE
Official Correspondent
  • Christopher - Hansche
  • 49-30-3198225-21
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressHohenzollerndamm 150-151
Berlin Berlin, 14199 DE
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3014090621
FEI Number3014090621
NameSOMATEX Medical Technologies GmbH
Owner & OperatorSOMATEX MEDICAL TECHNOLOGIES GMBH
Contact AddressHohenzollerndamm 150-151 --
Berlin DE-BE Berlin 14199 DE
Official Correspondent
  • Christopher - Hansche
  • 49-30-3198225-21
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressBlankenfelder Dorfstrasse 94
Blankenfelde-Mahlow Brandenburg, 15827 DE
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
SOMATEX Medical Technologies GmbH
Tumark® Professional Q for Brevera® Petite 2023-09-05
SOMATEX Medical Technologies GmbH
Tumark® Professional Q for Brevera® Standard 2023-09-05
SOMATEX Medical Technologies GmbH
Tumark® Professional X for Brevera® Petite 2023-09-05
SOMATEX Medical Technologies GmbH
Tumark® Professional X for Brevera® Standard 2023-09-05
SOMATEX Medical Technologies GmbH
Tumark® Vision for Brevera® Petite 2023-09-05
SOMATEX Medical Technologies GmbH
Tumark® Vision for Brevera® Standard 2023-09-05
SOMATEX Medical Technologies GmbH
Tumark® Professional Q for Eviva® Petite 2023-09-05
SOMATEX Medical Technologies GmbH
Tumark® Professional Q for Eviva® Standard 2023-09-05
SOMATEX Medical Technologies GmbH
Tumark® Professional X for Eviva® Petite 2023-09-05
SOMATEX Medical Technologies GmbH
Tumark® Professional X for Eviva® Standard 2023-09-05
SOMATEX Medical Technologies GmbH
Tumark® Vision for Eviva® Petite 2023-09-05
SOMATEX Medical Technologies GmbH
Tumark® Vision for Eviva® Standard 2023-09-05
SOMATEX Medical Technologies GmbH
Tumark Professional 2022-05-24
SOMATEX Medical Technologies GmbH
Tumark Professional 2022-05-24
SOMATEX Medical Technologies GmbH
MRI Tuloc 2021-11-05
SOMATEX Medical Technologies GmbH
MRI Tuloc 2021-11-05
SOMATEX Medical Technologies GmbH
Lung Marker System 2021-11-05
SOMATEX Medical Technologies GmbH
Lung Marker System 2021-11-05
SOMATEX Medical Technologies GmbH
Tuloc Premium 2021-11-05
SOMATEX Medical Technologies GmbH
Tuloc Premium 2021-11-05
SOMATEX Medical Technologies GmbH
Tuloc Premium 2021-11-05
SOMATEX Medical Technologies GmbH
Tuloc 2021-11-05
SOMATEX Medical Technologies GmbH
Tuloc 2021-11-05
SOMATEX Medical Technologies GmbH
Tuloc 2021-11-05
SOMATEX Medical Technologies GmbH
Q-Wire System 2021-11-05
SOMATEX Medical Technologies GmbH
Q-Wire System 2021-11-05
SOMATEX Medical Technologies GmbH
Q-Wire System 2021-11-05
SOMATEX Medical Technologies GmbH
Tumark Sphera 2021-10-18
SOMATEX Medical Technologies GmbH
Tumark Sphera 2021-10-18
SOMATEX Medical Technologies GmbH
Tumark Conic 2021-10-11
SOMATEX Medical Technologies GmbH
Tumark Conic 2021-10-11
SOMATEX Medical Technologies GmbH
Tumark Sphera 2021-08-09
SOMATEX Medical Technologies GmbH
Tumark Sphera 2021-08-09
SOMATEX Medical Technologies GmbH
Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape2021-02-18
SOMATEX Medical Technologies GmbH
Tuflex Premium 2020-09-08
SOMATEX Medical Technologies GmbH
Tuflex Premium 2020-09-08
SOMATEX Medical Technologies GmbH
Tuflex Premium 2020-09-08
SOMATEX Medical Technologies GmbH
Tuflex 2020-09-08
SOMATEX Medical Technologies GmbH
Tuflex 2020-09-08
SOMATEX Medical Technologies GmbH
Tuflex 2020-09-08
SOMATEX Medical Technologies GmbH
Tuflex 2020-09-08
SOMATEX Medical Technologies GmbH
Tumark Vision MRI 2019-01-01
SOMATEX Medical Technologies GmbH
Tumark® Professional Q for Brevera® Petite Tumark-BREV-P-Q2018-12-27
SOMATEX Medical Technologies GmbH
Tumark® Professional X for Brevera® Petite Tumark-BREV-P-X2018-12-27
SOMATEX Medical Technologies GmbH
Tumark® Professional X for Brevera® Standard Tumark-BREV-S-X2018-12-27
SOMATEX Medical Technologies GmbH
Tumark® Vision for Brevera® Petite Tumark-BREV-P-Vision2018-12-27
SOMATEX Medical Technologies GmbH
Tumark® Vision for Brevera® Standard Tumark-BREV-S-Vision2018-12-27
SOMATEX Medical Technologies GmbH
Tumark® Professional Q for Eviva® Petite Tumark-E13-P-Q2018-12-27
SOMATEX Medical Technologies GmbH
Tumark® Professional Q for Eviva® Standard Tumark-E13-S-Q2018-12-27
SOMATEX Medical Technologies GmbH
Tumark® Professional X for Eviva® Petite Tumark-E13-P-X2018-12-27
SOMATEX Medical Technologies GmbH
Tumark® Professional X for Eviva® Standard Tumark-E13-S-X2018-12-27
SOMATEX Medical Technologies GmbH
Tumark® Vision for Eviva® Petite Tumark-E13-P-Vision2018-12-27
SOMATEX Medical Technologies GmbH
Tumark® Vision for Eviva® Standard Tumark-E13-S-Vision2018-12-27
SOMATEX Medical Technologies GmbH
Tumark® Professional Q for Brevera® Standard Tumark-BREV-S-Q2018-12-27
SOMATEX Medical Technologies GmbH
Biopsy Handy 2018-12-18
SOMATEX Medical Technologies GmbH
TUMARK Flex 2715762018-11-30
SOMATEX Medical Technologies GmbH
TUMARK Flex 2715722018-11-30
SOMATEX Medical Technologies GmbH
TUMARK Flex 2715702018-11-30
SOMATEX Medical Technologies GmbH
TUMARK 2715502018-11-30
SOMATEX Medical Technologies GmbH
TUMARK Flex 2715742018-11-30
Somatex Medical Technologies GmbH
Tumark For Eviva, Tumark For Brevera2018-10-31
SOMATEX Medical Technologies GmbH
Duo System Stereo 2018-07-30
SOMATEX Medical Technologies GmbH
Duo System Stereo 2018-07-30
SOMATEX Medical Technologies GmbH
TUMARK Flex 3512522018-03-29
SOMATEX Medical Technologies GmbH
TUMARK Flex 3512502018-03-29
SOMATEX Medical Technologies GmbH
Tumark Vision 3512322018-03-29
SOMATEX Medical Technologies GmbH
Tumark Vision 3512302018-03-29
SOMATEX Medical Technologies GmbH
Tumark Professional Q-Shape 3512222018-03-29
SOMATEX Medical Technologies GmbH
Tumark Professional Q-Shape 3512202018-03-29
SOMATEX Medical Technologies GmbH
Tumark Professional X-Shape 3512122018-03-29
SOMATEX Medical Technologies GmbH
Tumark Professional X-Shape 3512102018-03-29
SOMATEX Medical Technologies GmbH
Tumark Eye 2018-03-29
SOMATEX Medical Technologies GmbH
Tumark Eye 2715102018-03-29
SOMATEX Medical Technologies GmbH
Tumark Professional Q-Shape 2018-03-29
SOMATEX Medical Technologies GmbH
Tumark Vision 2715892018-03-29
SOMATEX Medical Technologies GmbH
Tumark Vision 2715902018-03-29
SOMATEX Medical Technologies GmbH
Tumark Professional X-Shape 2715512018-03-29
SOMATEX Medical Technologies GmbH
TUMARK Professional X-Shape 2715492018-03-29
SOMATEX Medical Technologies GmbH
Tumark Professional Q-Shape 2715482018-03-29
SOMATEX Medical Technologies GmbH
Biopsy Handy 2018-03-29
SOMATEX Medical Technologies GmbH
Biopsy Handy 2018-03-29
SOMATEX Medical Technologies GmbH
Biopsy Handy 2018-03-29
SOMATEX Medical Technologies GmbH
Biopsy Handy 2018-03-29
SOMATEX Medical Technologies GmbH
Biopsy Handy 2018-03-29
SOMATEX Medical Technologies GmbH
Biopsy Handy 2018-03-29
SOMATEX Medical Technologies GmbH
Biopsy Handy 2018-03-29
SOMATEX Medical Technologies GmbH
Biopsy Handy 2018-03-29
SOMATEX Medical Technologies GmbH
Biopsy Handy 2018-03-29
SOMATEX Medical Technologies GmbH
MRI Biopsy Handy 2018-03-29
SOMATEX Medical Technologies GmbH
Tumark MRI 6015702018-03-29
SOMATEX Medical Technologies GmbH
TUMARK Professional 2715652018-03-29
SOMATEX Medical Technologies GmbH
TUMARK Professional 2715602018-03-29
SOMATEX Medical Technologies GmbH
TUMARK Q 2715002018-03-29
SOMATEX Medical Technologies GmbH
TUMARK Professional 2715572018-03-29
SOMATEX Medical Technologies GmbH
TUMARK Professional 2715592018-03-29
SOMATEX Medical Technologies GmbH
Biopsy Handy 2018-03-29
SOMATEX Medical Technologies GmbH
Biopsy Handy 2018-03-29
SOMATEX Medical Technologies GmbH
MRI Biopsy Handy 2018-03-29
SOMATEX Medical Technologies GmbH
Tumark Vision2018-03-22
SOMATEX MEDICAL TECHNOLOGIES GMBH
TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC2011-11-08
SOMATEX MEDICAL TECHNOLOGIES GMBH
BIOPSY HANDY, MRI BIOPSY HANDY2011-06-24
SOMATEX MEDICAL TECHNOLOGIES GMBH
TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 6015602010-02-17
SOMATEX MEDICAL TECHNOLOGIES GMBH
TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 6015602008-03-19

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