MedtechSourcebook

BGS US LLC

Contract sterilizer ยท Imperial, PA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2025Product codes first listed, by year (tallest: 2)2026
FDA registration
3032902763 (openFDA record; or search FDA's registration database)
FEI number
3032902763
Registered for
FDA registration year 2026
Establishment types
Contract sterilizer
Owner or operator
BGS US LLC (FDA owner/operator no. 10092957)
Registered address
151 Arthur Ct, Imperial, PA 15126
Contract listings
3 device listings, 3 product codes, first listed Sep 18, 2025
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
DXTInjector And Syringe, AngiographicClass IICardiovascularContract sterilizationSep 4, 2026
GKTSeparator, Automated, Blood Cell, DiagnosticClass IIHematologyContract sterilizationSep 18, 2025
KSRContainer, Empty, For Collection & Processing Of Blood & Blood ComponentsClass IIHematologyContract sterilizationDec 2, 2025