Smiths Medical Czech Republic A S

FDA Filings

This page includes the latest FDA filings for Smiths Medical Czech Republic A S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011237704
• FEI Number: 3011237704
• Name: Smiths Medical Czech Republic a.s.
• Owner & Operator: SMITHS GROUP PLC
• Contact Address: 4th Floor 11-12 St James Square; London GB-NOTA SW1Y 4LB GB
• US Agent:
  • Jeffrey Duncan
  • SMITHS MEDICAL ASD, INC.
  • 612 2062917
  • jeffrey.duncan@smiths-medical.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Olomoucka 306 ; Hranice Olomoucky kraj, 753 01 CZ
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 35019315107287 Smiths Medical Czech Republic a.s.	Portex	2020-06-30
GUDID 55019315104846 Smiths Medical Czech Republic a.s.	Portex	2020-03-20
GUDID 35019315104880 Smiths Medical Czech Republic a.s.	Portex	2020-03-20
GUDID 35019315104873 Smiths Medical Czech Republic a.s.	Portex	2020-03-20
GUDID 35019315104866 Smiths Medical Czech Republic a.s.	Portex	2020-03-20
GUDID 35019315104859 Smiths Medical Czech Republic a.s.	Portex	2020-03-20
GUDID 35019315104835 Smiths Medical Czech Republic a.s.	Portex	2020-03-20
GUDID 15019315110528 Smiths Medical Czech Republic a.s.	Portex	2019-06-24
PMN K173912 | JOH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	BLUperc Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect Tracheostomy Tube	2018-11-09
PMN K173912 | JOH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	BLUgriggs Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect Tracheostomy Tube with or without	2018-11-09
PMN K173912 | BTO Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	BLUperc Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect Tracheostomy Tube	2018-11-09
PMN K173912 | BTO Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	BLUgriggs Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect Tracheostomy Tube with or without	2018-11-09
PMN K173384 | BTO Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex BLUselect Tracheostomy Tube	2018-11-09
PMN K173384 | BTO Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex BLUselect Tracheostomy Inner Cannula	2018-11-09
PMN K173384 | BTO Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex BLUselect Suctionaid Tracheostomy Tube	2018-11-09
GUDID 55019315107144 Smiths Medical Czech Republic a.s.	Portex	2018-10-16
GUDID 55019315106604 Smiths Medical Czech Republic a.s.	Portex	2018-10-16
GUDID 55019315103016 Smiths Medical Czech Republic a.s.	Portex	2018-10-16
GUDID 35019315106754 Smiths Medical Czech Republic a.s.	Portex	2018-10-16
GUDID 35019315106662 Smiths Medical Czech Republic a.s.	Portex	2018-10-16
GUDID 35019315106617 Smiths Medical Czech Republic a.s.	Portex	2018-10-16
GUDID 55019315107243 Smiths Medical Czech Republic a.s.	Portex	2018-10-08
GUDID 55019315107236 Smiths Medical Czech Republic a.s.	Portex	2018-10-08
GUDID 55019315107229 Smiths Medical Czech Republic a.s.	Portex	2018-10-08
GUDID 55019315107199 Smiths Medical Czech Republic a.s.	Portex	2018-10-08
GUDID 55019315106888 Smiths Medical Czech Republic a.s.	Portex	2018-10-08
GUDID 35019315107201 Smiths Medical Czech Republic a.s.	Portex	2018-10-08
GUDID 35019315107157 Smiths Medical Czech Republic a.s.	Portex	2018-10-08
GUDID 35019315106907 Smiths Medical Czech Republic a.s.	Portex	2018-10-08
GUDID 35019315106891 Smiths Medical Czech Republic a.s.	Portex	2018-10-08
GUDID 55019315107212 Smiths Medical Czech Republic a.s.	Portex	2018-10-05
PMN K172410 | MIA Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex L.O.R. Syringes with NRFit Connector	2018-08-15
PMN K172410 | MIA Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Filter Straw with NRFit Connector	2018-08-15
PMN K172410 | MIA Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Filter Needle with NRFit Connector	2018-08-15
PMN K172410 | MIA Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Epidural Flat Filter with NRFit Connector	2018-08-15
PMN K172410 | MIA Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex EpiFuse Catheter with NRFit Connector	2018-08-15
PMN K172410 | CAZ Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex L.O.R. Syringes with NRFit Connector	2018-08-15
PMN K172410 | CAZ Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Filter Straw with NRFit Connector	2018-08-15
PMN K172410 | CAZ Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Filter Needle with NRFit Connector	2018-08-15
PMN K172410 | CAZ Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Epidural Flat Filter with NRFit Connector	2018-08-15
PMN K172410 | CAZ Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex EpiFuse Catheter with NRFit Connector	2018-08-15
PMN K172410 | BSP Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex L.O.R. Syringes with NRFit Connector	2018-08-15
PMN K172410 | BSP Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Filter Straw with NRFit Connector	2018-08-15
PMN K172410 | BSP Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Filter Needle with NRFit Connector	2018-08-15
PMN K172410 | BSP Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Epidural Flat Filter with NRFit Connector	2018-08-15
PMN K172410 | BSP Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex EpiFuse Catheter with NRFit Connector	2018-08-15
PMN K172410 | BSN Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex L.O.R. Syringes with NRFit Connector	2018-08-15
PMN K172410 | BSN Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Filter Straw with NRFit Connector	2018-08-15
PMN K172410 | BSN Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Filter Needle with NRFit Connector	2018-08-15
PMN K172410 | BSN Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Epidural Flat Filter with NRFit Connector	2018-08-15
PMN K172410 | BSN Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex EpiFuse Catheter with NRFit Connector	2018-08-15
GUDID 55019315106871 Smiths Medical Czech Republic a.s.	Portex	2018-07-06
GUDID 55019315107182 Smiths Medical Czech Republic a.s.	Portex	2018-03-29
GUDID 55019315107175 Smiths Medical Czech Republic a.s.	Portex	2018-03-29
GUDID 55019315106956 Smiths Medical Czech Republic a.s.	Portex	2018-03-29
GUDID 55019315103009 Smiths Medical Czech Republic a.s.	Portex	2018-03-29
GUDID 35019315110522 Smiths Medical Czech Republic a.s.	Portex	2018-03-29
GUDID 35019315107164 Smiths Medical Czech Republic a.s.	Portex	2018-03-29
GUDID 35019315106952 Smiths Medical Czech Republic a.s.	Portex	2018-03-29
GUDID 35019315106761 Smiths Medical Czech Republic a.s.	Portex	2018-03-29
GUDID 15019315106958 Smiths Medical Czech Republic a.s.	Portex	2018-03-29
PMN K162219 | PWH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Male Yellow Cap with NRFit? connector	2017-09-13
PMN K162219 | PWH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Female Yellow Cap with NRFit? connector	2017-09-13
PMN K162219 | PWH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	CADD? Yellow Medication Cassette Reservoir with NRFit? connector	2017-09-13
PMN K162219 | PWH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	CADD? Yellow Extension Sets with NRFit? connector	2017-09-13
PMN K162219 | PWH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	CADD? Yellow Administration Set with NRFit? connector	2017-09-13
PMN K162219 | PWH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	CADD? Infusion Adapter with male NRFit? connector and female Luer	2017-09-13
PMN K162219 | PWH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	CADD? Filling Adapter with male NRFit? connector and female Luer	2017-09-13
PMN K162219 | LHI Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Male Yellow Cap with NRFit? connector	2017-09-13
PMN K162219 | LHI Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Female Yellow Cap with NRFit? connector	2017-09-13
PMN K162219 | LHI Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	CADD? Yellow Medication Cassette Reservoir with NRFit? connector	2017-09-13
PMN K162219 | LHI Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	CADD? Yellow Extension Sets with NRFit? connector	2017-09-13
PMN K162219 | LHI Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	CADD? Yellow Administration Set with NRFit? connector	2017-09-13
PMN K162219 | LHI Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	CADD? Infusion Adapter with male NRFit? connector and female Luer	2017-09-13
PMN K162219 | LHI Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	CADD? Filling Adapter with male NRFit? connector and female Luer	2017-09-13
PMN K050166 | BWC Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Emergency Cricothyroidotomy	2010-04-07
PMN K050166 | BWC Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Emergency Cricothyroidotomy Kit	2010-04-07
PMN K083031 | BTO Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	UniPerc Percutaneous Dilation Tracheostomy Kit	2009-08-31
PMN K083031 | BTO Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	UniPerc PDT Kit	2009-08-31
PMN K083031 | BTO Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	UniPerc Adjustable Flange Tracheostomy Tube	2009-08-31
PMN K083031 | BTO Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex	2009-08-31
PMN K083451 | BSN Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Epidural Filter	2009-03-19
PMN K060945 | BTO Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	PORTEX GRIGGS PERC TRACH KITS	2007-12-04
PMN K060945 | BTO Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	PERC TRACH KIT with Forceps	2007-12-04
PMN K060945 | BTO Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	BLUS	2007-12-04
PMN K060945 | BTO Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	BLU	2007-12-04
PMN K041348 | JOH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex ULTRAperc tracheostomy apparatus and instruments	2007-06-06
PMN K041348 | JOH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Percutaneous Dilation Tracheostomy Kit	2007-06-06
PMN K041348 | JOH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Blue Line Ultra? tracheostomy tubes	2007-06-06
PMN K041348 | JOH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	PORTEX ULTRAPERC	2007-06-06
PMN K040014 | JOH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex Percutaneous Dilation Trachesotomy kit	2007-06-06
PMN K040014 | JOH Smiths Medical Czech Republic a.s. [SMITHS GROUP PLC]	Portex PDT Trachesotomy kit	2007-06-06

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092266136	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL SUPPLIES HS:901839	2 SKD
2020091965730	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL SUPPLIES HS:901839	2 SKD
2020091668843	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL SUPPLIES HS:901839	2 SKD
2020062464751	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	HS CODE: 390422	1 PKG