Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038219378

FEI Number

3038219378

Entity Name

SUPERMAX HEALTHCARE CANADA INC.

City/State/Country

Longueuil Quebec, CA

Establishment Address

766-B Beriault St, Longueuil Quebec J4G 1R8, CA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Supermax Healthcare Canada (Owner Number: 10093349)

Owner / Operator Contact Address

1001 Rue Jean Talon, St-Bruno-de-Montarville, CA-QC J3V 0N3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242502

PMA Number

N/A

All Registered Proprietary Names

Aurelia Surgical Mask ASTM Level 2 Aurelia Surgical Mask ASTM Level 1 Aurelia Surgical Mask ASTM Level-3 (2130)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-05-05
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-05-05

Official Correspondent

Bharti Bhadana

US Agent Details

Sajeev Joseph Email: sajeev.joseph@maxtergloves.com Phone: (713) 2821136

Related Public Records

Same Entity

Supermax Healthcare Canada

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038219378. Last updated year: 2026. Please use registration number 3038219378 when referencing this establishment in official correspondence.