Hubert De Backer N V

FDA Filings

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

FDA Registration(s)

• Registration Number: 3003192903
• FEI Number: 3003192903
• Name: Lee Leichter
• Owner & Operator: Hubert De Backer n.v.
• Contact Address: Laagstraat 59 ; Temse BE-VOV Oost-Vlaanderen B-9140 BE
• Official Correspondent:
  • Niels D'hondt
  • 32-3-7763494-x
• US Agent:
  • Lee Leichter
  • P/L Biomedical
  • 239 2441448
  • leichter@plbiomedical.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10882 Stonington Avenue ; Fort Myers, FL 33913 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
KYX Lee Leichter [Hubert De Backer n.v.]	T2174/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2170 + T2043	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2166 + T2046	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2165 + T2023	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2164/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2163/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2149/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2148/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2143	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2143/A	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2142	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2142/A	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2121 + T2115	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2120 + T2064	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2116 + T2115	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2061 + T2060	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2059/1A	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2059/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2057/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2049	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2048	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2047 + T2046	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2045	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2044 + T2043	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2041/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2040/2	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2035	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2033	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2030	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2029/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2024 + T2023	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2010/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2008	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2007	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T2006	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1999	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1998	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1985	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1984	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1965/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1959	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1958	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1939	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1938	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1891	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1890/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1883	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1880	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1878	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1877	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1870	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1869/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1868	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1867/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1853/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1852	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1840 + T2064	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1840 + T1939/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1765/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1754	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1753	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1743	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1706/2	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1703/1 + T2150	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1703/1 + T1907/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1693/1A	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1687/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1685/2	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1681 + T1906/2	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1673/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1670/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1668	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1666/4	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1635/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1631/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1630/2B	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1630/2	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1602/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1587/5	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1586/1A	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1583/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1582/2	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1581/2	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1539/2A	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1485/1	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1333/3	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	T1302/3	2010-06-24
KYX Lee Leichter [Hubert De Backer n.v.]	BEGR.9037	2010-06-24

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200815367	Anvers,Belgium -> New York, New York	STC ORAL SYRINGE LOADED AS 3 PALLETS HS-CODE 90183110 CONTACT DETAILS AS PER SHIPPER S DECLARATION	3 PKG
2020041040490	Anvers,Belgium -> Charleston, South Carolina	6 PALLETPLACES 11 BOX PALLETS AND 1 PALLET WITH 2 BOXES JERINGA 30 ML META SUSP 15MG ME	13 PCS
2020040930934	Anvers,Belgium -> Charleston, South Carolina	6 PALLETPLACES 11 BOX PALLETS AND 1 PALLET WITH 2 BOXES JERINGA 30 ML META SUSP 15MG ME	13 PCS
2020032036389	Anvers,Belgium -> Charleston, South Carolina	8 PALLETPLACES 15 BOX PALLETS JERINGA HDB 2 ML PO 155254 HS CODE 90183110 COUNTRY OF O	15 PCS
202003109627	Anvers,Belgium -> Charleston, South Carolina	JERINGA 3 ML METACAM SUSPENSION LOADED ONTO 1 8 BOX PALLETS PO 149355 2 HS CODE 90183110	9 PCS
2020022133211	Anvers,Belgium -> Charleston, South Carolina	JERINGA 3 ML METACAM SUSPENSION LOADED ONTO 1 8 BOX PALLETS PO 149355 2 HS CODE 90183110	9 PCS
2020010875747	Anvers,Belgium -> New York, New York	STC ORAL SYRINGE LOADED AS 3 PALLETS HS-CODE 90183110 CONTACT DETAILS AS PER SHIPPER S DECLARATION	3 PKG
2019080633266	Anvers,Belgium -> Charleston, South Carolina	SLAC INSERTO PLUG-IN HDB TELMI PO 143993 HS CODE 90183110 COUNTRY OF ORIGIN BELGIUM IN	21 PCS