Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003192903

FEI Number

3003192903

Entity Name

HUBERT DE BACKER N.V.

City/State/Country

Temse Oost-Vlaanderen, BE

Establishment Address

Laagstraat 59, Temse Oost-Vlaanderen 9140, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hubert De Backer n.v. (Owner Number: 10032923)

Owner / Operator Contact Address

Laagstraat 59, Temse, BE-VOV B-9140, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

T2188+T2187 T2248 T2249 T2244+T2243 T1670/1 T1765/1 T1673/1 T1840+T2064/A T2238 T1635/1 T2121+T2201 T2149/1 T1302/3 T2116+T2115 T1703/1+T2192/1 T2059/1A T1706/2 T1582/2 T1539/2A T2143/A T2120/A+T2064/A T1703/1+T1907/1A T1764 T1958 T1965/1 T2126+T2125 T2120+T2064/B T1703/1+T1907/2 T1999 T1889/1 T1880 T2044+T2043/A T1703/1+T1907/1 T2040/3 T1630/2B T2045 T1840/A+T2064/B T1703/1+T2192 T1998 T1877 T1840+T1839/1 T2041/2 T1852 T1853/2 T2164/1 T2007 T2121+T2115 T1703/1+T2240 T2148/2 T1583/1 T2163/1 T2193 T1890/1 T2165+T2023 T1703/1+T2150/1 T1485/1 T1581/2 T1878 T2142 T2120+T2064/A T1959 T2033 T2006 T2047+T2046 T2029/1 T2188+T2191 T2010/1 T1668 T2035 T1883 T2120/A+T2064/B T2164/2 T2008 T2188+T2239 T2010/2 T1743 T2186 T2166+T2046 T2030 T2170+T2043 T2200+T2197 T2040/2 T1630/2 T2049 T2024+T2023 T1703/1+T1907/2A T1687/1 T1870 T2048 T1840+T2064/B T1703/1+T2150 T1938 T1868 T1840/A+T1839/1 T2057/1 T2174/1 T1869/1 T1891/1 T1840/A+T2064/A T1685/2 T1602/1 T2061+T2060 T1753 T1985 T2061+T2060/A T1754 T1693/1A T2163/2 T2195 T1840+T2064 T2120/A+T2064 T2227/1 T1840+T2196 T1840/A+T2064 T2059/2 T2226/1 T2044+T2043 T2149/2 T1867/1 T1840+T1839/1A T2057/2 T2174/2 T1879 T1840/A+T1839/1A T2059/1 T2226 T2143 T2222+T2115 T1703/1+T2194/1 T2148/1 T1666/4 T1631/1 T2170+T2043/A T2041/1 T1984 T1939 T1840/A+T2196 T2120+T2064 T2227 T2173+T2115 T1703/1+T2194 T2059/2A T1587/5 T1586/1A T2142/A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2010-06-24

Official Correspondent

Niels D'hondt

US Agent Details

Lee Leichter Business: P/L Biomedical Email: leichter@plbiomedical.com Phone: (239) 9946488

Related Public Records

Same Entity

Hubert De Backer n.v.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003192903. Last updated year: 2026. Please use registration number 3003192903 when referencing this establishment in official correspondence.