Swiss Bionic Solutions Schweiz G M B H

FDA Filings

This page includes the latest FDA filings for Swiss Bionic Solutions Schweiz 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 Number3007791564
FEI Number3007791564
NameSwiss Bionic Solutions GmbH
Owner & OperatorSwiss Bionic Solutions Schweiz GmbH
Contact AddressSchulhausstrasse 17
Schindellegi CH-SZ Schwyz 8834 CH
Official Correspondent
  • Wolfgang Jaksch
  • 041-62-2955951-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressSchulhausstrasse 17
Schindelleg Schwyz, 8834 CH
Establishment TypeManufacture Medical Device



Registration Number3007817152
FEI Number3007817152
NameSwiss Bionic Solutions USA Inc.
Owner & OperatorSwiss Bionic Solutions Schweiz GmbH
Contact AddressSchulhausstrasse 17
Schindellegi CH-SZ Schwyz 8834 CH
Official Correspondent
  • Wolfgang Jaksch
  • 041-62-2955951-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address12330 SW 53rd Street Suite 703 & 704
Cooper City, FL 33330 US



FDA Filings

Device
Company
DeviceDate
Swiss Bionic Solutions GmbH [Swiss Bionic Solutions Schweiz GmbH]
Exagon FIR2020-03-31
Swiss Bionic Solutions GmbH [Swiss Bionic Solutions Schweiz GmbH]
iMRS2009-06-12
Swiss Bionic Solutions GmbH [Swiss Bionic Solutions Schweiz GmbH]
SKINDREAM TITANIUM2009-06-12
Swiss Bionic Solutions GmbH [Swiss Bionic Solutions Schweiz GmbH]
Omnium12009-06-12
Swiss Bionic Solutions GmbH [Swiss Bionic Solutions Schweiz GmbH]
MRS 2000+designo HOME and MED2009-06-12
Swiss Bionic Solutions GmbH [Swiss Bionic Solutions Schweiz GmbH]
OmniBrain2009-06-11
Swiss Bionic Solutions GmbH [Swiss Bionic Solutions Schweiz GmbH]
Exagon Sense2009-06-11
Swiss Bionic Solutions GmbH [Swiss Bionic Solutions Schweiz GmbH]
Exagon Brain2009-06-11

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020081857637Anvers,Belgium -> Port Everglades, FloridaMECH-THRPY APPL MSSG APPR PSYCH APT-TEST A IMRS BASIC SET IMRS TRAVEL BAG OMISPOT COTTON FLEX IMRS COTTON FLEX OMNIUM 111 PKG
2020072136654Anvers,Belgium -> Port Everglades, FloridaMECH-THRPY APPL MSSG APPR PSYCH APT-TEST A IMRS BASIC SET IMRS TRAVEL BAG OMISPOT COTTON FLEX IMRS COTTON FLEX OMNIUM 111 PKG
2020042132174Anvers,Belgium -> Port Everglades, FloridaMECH-THRPY APPL MSSG APPR PSYCH APT-TEST A IMRS PRIME BASIC IMRS ONE 2.0 BASIC SET (WITHOUT TABLET) HS 9019.100 NOT STACKABLE11 PKG
2020022535809Anvers,Belgium -> Port Everglades, FloridaMECH-THRPY APPL MSSG APPR PSYCH APT-TEST A 11 PACKAGES IMRS WELLFIT IMRS BASIC SET IMRS POWER SPPLY EXAGON SENSE BIOFEEDBACK11 PKG
2019111530963Rotterdam,Netherlands -> Miami, FloridaIMRS BASIC SET IMRS OUTER BOX HS-CODE 9019.1 000 US THC CUC PREPAID11 PCS
2019110118493Rotterdam,Netherlands -> Miami, FloridaIMRS BASIC SET HS-CODE 9019.1000 US THC CU C PREPAID11 PCS
2019101144325Rotterdam,Netherlands -> Miami, FloridaIMRS BASIC SET HS-CODE 9019.1000 US THC CU C PREPAID11 PCS
2019091853829Rotterdam,Netherlands -> Miami, FloridaIMRS BASIC SET HS-CODE 9019.1000 US THC CU C PREPAID11 PCS

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