Ergoline G M B H

FDA Filings

This page includes the latest FDA filings for Ergoline 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 Number3005438755
FEI Number3005438755
NameERGOLINE GMBH
Owner & OperatorERGOLINE GMBH
Contact AddressLINDENSTR. 5 --
BITZ, B-W DE-NOTA 72475 DE
Official Correspondent
  • AXEL - BODMER
  • 49-743-198940-x
US Agent
Importing Logistics Registration
ImporterGE Healthcare
Address465 Pan America Dr. Suite 11
El Paso, TX 79907 UNITED STATES
Importer TypeRETAILER
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressLINDENSTR. 5
BITZ Baden-Wurttemberg, 72475 DE
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
Ergoline GmbH
Ers2 - Ergoline Rehabilitation System2022-07-15
ergoline GmbH
Couch Ergometer ergoselect 12, T unit 2018-04-30
ergoline GmbH
Couch Ergometer ergoselect 12, P unit, Bluetooth 2018-04-30
ergoline GmbH
Couch Ergometer ergoselect 12, P unit 2018-04-30
ergoline GmbH
Couch Ergometer ergoselect 12, wireless remote con 2018-04-30
ergoline GmbH
Couch Ergometer ergoselect 12, Twin castors, Bluet 2018-04-30
ergoline GmbH
Couch Ergometer ergoselect 12, Bluetooth 2018-04-30
ergoline GmbH
Couch Ergometer ergoselect 12 2018-04-30
ergoline GmbH
Recumbent Ergometer ergoselect 600 P BP 2018-04-06
ergoline GmbH
Recumbent Ergometer ergoselect 600 P 2018-04-06
ergoline GmbH
ERGOMETER ergoselect 5 T 2018-03-29
ergoline GmbH
ERGOMETER ergoselect 5 P 2018-03-29
ergoline GmbH
ERGOMETER ergoselect 5 M 2018-03-29
ergoline GmbH
ERGOMETER ergoselect 4 T 2018-03-29
ergoline GmbH
ERGOMETER ergoselect 4 P 2018-03-29
ergoline GmbH
ERGOMETER ergoselect 4 M 2018-03-29
ergoline GmbH
ERGOMETER EBIKE III COMFORT 2018-03-29
ergoline GmbH
ERGOMETER EBIKE III Basic 2018-03-29
ergoline GmbH
SPLY EBIKE CUFF ADULT SMALL 2018-03-29
ergoline GmbH
SPLY EBIKE CUFF ADULT LARGE 2018-03-29
ergoline GmbH
SPLY EBIKE CUFF ADULT 2018-03-29
ergoline GmbH
Blood pressure cuff with microphone, large 2018-03-29
ergoline GmbH
Blood pressure cuff with microphone, small 2018-03-29
ergoline GmbH
Blood pressure cuff with microphone, standard, wid 2018-03-29
ergoline GmbH
COM module for use with the MAC 5500 ST electrocar 2018-03-29
ergoline GmbH
blood pressure cuff (BNC), large 2018-03-29
ergoline GmbH
blood pressure cuff (BNC), small 2018-03-29
ergoline GmbH
blood pressure cuff (BNC), standard 2018-03-29
ergoline GmbH
Analogue Interface Module ergoselect2 2018-03-29
ergoline GmbH
Blood Pressure Cuff, infant 2018-03-29
ergoline GmbH
Blood Pressure Cuff, large 2018-03-29
ergoline GmbH
Blood Pressure Cuff, Standard 2018-03-29
ergoline GmbH
Couch Ergometer ergoselect 1200 EL 120V K 2018-03-29
ergoline GmbH
Couch Ergometer ergoselect 1200 EL 230V P BP 2018-03-29
ergoline GmbH
Recumbent Ergometer ergoselect 600 K HF 2018-03-29
ergoline GmbH
Seat Ergometer ergoselect 200 P BP 2018-03-29
ergoline GmbH
Seat Ergometer ergoselect 100 K BP, SpO2 2018-03-29
ergoline GmbH
Seat Ergometer ergoselect 100 P BP 2018-03-29
ergoline GmbH
Seat Ergometer ergoselect 200 K BP 2018-03-29
ergoline GmbH
Seat Ergometer ergoselect 200 K 2018-03-29
ergoline GmbH
Seat Ergometer ergoselect 200 P 2018-03-29
ergoline GmbH
Seat Ergometer ergoselect 100 K BP 2018-03-29
ergoline GmbH
Seat Ergometer ergoselect 100 K 2018-03-29
ergoline GmbH
Seat Ergometer ergoselect 100 P 2018-03-29
ergoline GmbH
Seat Ergometer viasprint 150 P BP Viasys 2018-03-29
ergoline GmbH
Seat Ergometer viasprint 150 P Viasys 2018-03-29
ergoline GmbH
SYSTEM EBIKE EL & BP EXT TRMNL 120V US 2018-03-29
ergoline GmbH
SYSTEM EBIKE EL EXT TRMNL 120V US 2018-03-29
ergoline GmbH
SYSTEM EBIKE EL & BP 120V US 2018-03-29
ergoline GmbH
SYSTEM EBIKE EL 120V US 2018-03-29
ergoline GmbH
SYSTEM EBIKE L & BP EXT TRMNL 120V US 2018-03-29
ergoline GmbH
SYSTEM EBIKE L EXT TRMNL 120V US 2018-03-29
ergoline GmbH
SYSTEM EBIKE L & BP 120V US 2018-03-29
ergoline GmbH
SYSTEM EBIKE L 120V US 2018-03-29
ergoline GmbH
SYSTEM EBIKE COMFORT US & BP 2018-03-29
ergoline GmbH
SYSTEM EBIKE COMFORT US 2018-03-29
ergoline GmbH
SYSTEM EBIKE BASIC US & BP 2018-03-29
ergoline GmbH
SYSTEM EBIKE BASIC US 2018-03-29
ergoline GmbH
ERGOMETER EBIKE EL & BP EXT TRMNL 120V US 2018-03-29
ergoline GmbH
ERGOMETER EBIKE EL EXT TRMNL 120V US 2018-03-29
ergoline GmbH
ERGOMETER EBIKE EL & BP 120V US 2018-03-29
ergoline GmbH
ERGOMETER EBIKE EL 120V US 2018-03-29
ergoline GmbH
ERGOMETER EBIKE L & BP EXT TRMNL 120V US 2018-03-29
ergoline GmbH
ERGOMETER EBIKE L EXT TRMNL 120V US 2018-03-29
ergoline GmbH
ERGOMETER EBIKE L & BP 120V US 2018-03-29
ergoline GmbH
ERGOMETER EBIKE L 120V US 2018-03-29
ergoline GmbH
ERGOMETER EBIKE COMFORT US & BP 2018-03-29
ergoline GmbH
ERGOMETER EBIKE COMFORT US 2018-03-29
ergoline GmbH
ERGOMETER EBIKE BASIC US & BP 2018-03-29
ergoline GmbH
ERGOMETER EBIKE BASIC US 2018-03-29
ERGOLINE GMBH
ERGOSELECT/GE2012-10-31
ERGOLINE GMBH
Treadmill accessories2012-04-18
ERGOLINE GMBH
Infusion holder2012-04-18
ERGOLINE GMBH
ergocar PC/basic2010-12-02
ERGOLINE GMBH
ebike incl. NiBP-Modul2008-07-16
ERGOLINE GMBH
ebike 2L2008-07-16
ERGOLINE GMBH
ebike 2 comfort2008-07-16
ERGOLINE GMBH
ebike 2 basic2008-07-16
ERGOLINE GMBH
ebike 2 EL2008-07-16
ERGOLINE GMBH
eBike comfort series2008-07-16
ERGOLINE GMBH
eBike basic series2008-07-16
ERGOLINE GMBH
eBike RC series2008-07-16
ERGOLINE GMBH
eBike L series2008-07-16
ERGOLINE GMBH
eBike EL series2008-07-16
ERGOLINE GMBH
Ergoselect incl. Module NIBP2008-07-16
ERGOLINE GMBH
Ergoselect Series2008-07-16
ERGOLINE GMBH
Ergoselect 1200EL/1000L2008-07-10
ERGOLINE GMBH
ERGOSELECT 100 K/P, ERGOSELECT 200 K/P2006-04-27
ERGOLINE GMBH
Ergoselect 600 series2005-10-26
ERGOLINE GMBH
Ergoselect 200 series2005-10-26
ERGOLINE GMBH
Ergoselect 1200 series2005-10-26
ERGOLINE GMBH
Ergoselect 1000 series2005-10-26
ERGOLINE GMBH
Ergoselect 100 series2005-10-26
ERGOLINE GMBH
ERGOSELECT 1002005-10-26
ERGOLINE GMBH
200 P2005-10-26

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091018890Stadersand,Federal Republic of Germany -> Los Angeles, CaliforniaVIASPRINT 150P WITH BP HS CODE: 95069110 PKG
2020052711413Stadersand,Federal Republic of Germany -> Oakland, CaliforniaERGOSELECT ERGOSELECT 100 K WITHOUT BLOOD PRESSURE, ERGOSELECT 100 P WITHOUT BLOOD PRESSURE, ERGOSELECT 200 K WITHOUT BLOOD PRESSURE22 PCS
202004221727Stadersand,Federal Republic of Germany -> Los Angeles, CaliforniaVIASPRINT 150P WITH BP HS-CODE: 9506918 PKG
202004162565Stadersand,Federal Republic of Germany -> Los Angeles, CaliforniaVIASPRINT 150P WITH BP HS-CODE: 9506918 PKG
202004143353Stadersand,Federal Republic of Germany -> Los Angeles, CaliforniaVIASPRINT 150P WITH BP HS-CODE: 9506918 PKG
202004068977Stadersand,Federal Republic of Germany -> Los Angeles, CaliforniaVIASPRINT 150P WITH BP HS-CODE: 9506918 PKG
2019121952335Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyERGOSELECT 100 P WITHOUT BLOOD PRESSURE HS-CODE: 9506911 PKG
2019121952336Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyERGOSELECT 100 P WITHOUT BLOOD PRESSURE HS-CODE: 9506911 PKG

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