Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032902763

FEI Number

3032902763

Entity Name

BGS US LLC

City/State/Country

Imperial, PA, US

Establishment Address

151 Arthur Ct, Imperial, PA 15126, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

BGS US LLC (Owner Number: 10092957)

Owner / Operator Contact Address

151 Arthur Ct, Imperial, PA 15126, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2025-12-02
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2025-09-18

Official Correspondent

James Arbogast

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BGS US LLC

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 3032902763. Last updated year: 2026. Please use registration number 3032902763 when referencing this establishment in official correspondence.