EZEM CANADA INC

FDA Device Registration & Listing · Anjou Quebec, CA · Registration 8022029

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8022029
FEI Number
3002808342
Entity Name
EZEM CANADA INC
City/State/Country
Anjou Quebec, CA
Establishment Address
11065 Boul L-H Lafontaine, Anjou Quebec H1J 2Z4, CA
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
EZEM canada Inc (Owner Number: 10094286)
Owner / Operator Contact Address
11065 Boul L-H Lafontaine, Anjou, CA-QC H1J 2Z4, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Vented Cap for Waste Bottle for use with CardioGen-82 Infusion System Elution Test Vial Bottle use with CardioGen-82 Infusion System Waste Bottle for use with CardioGen-82 Infusion System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IWW Shield, Vial Radiology Class 1 892.6500 2025-11-21

Official Correspondent

Claude Briand

US Agent Details

Elyssa Murray Business: Bracco Diagnostics, Inc. Email: Elyssa.Murray@diag.bracco.com Phone: (609) 5242854

Related Public Records

Same Entity

EZEM canada Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3008627763 I-Tek Medical, Inc. White Bear Lake, MN, US
3009088444 Sirtex Singapore Manufacturing Pte Ltd Singapore Central Singapore, SG
3016739098 SOUTH WEST EXPOSURES (2566031 ONT INC.) Toronto Ontario, CA
2518443 MIRION TECHNOLOGIES (CAPINTEC), INC Florham Park, NJ, US
3007369190 ULTRARAY GROUP INC. Oakville Ontario, CA
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022029. Last updated year: 2026. Please use registration number 8022029 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.