Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681702

FEI Number

3003749234

Entity Name

BATRIK MEDICAL MANUFACTURING INC.

City/State/Country

Lachine Quebec, CA

Establishment Address

2165 46th Avenue, Lachine Quebec H8T 2P1, CA

Establishment Type(s)

Manufacture Medical Device,Repack or Relabel Medical Device

Owner / Operator

BATRIK MEDICAL MANUFACTURING INC. (Owner Number: 9026328)

Owner / Operator Contact Address

2165 46e Avenue, --, Lachine, CA-QC H8T 2P1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bitestrong Vascular Silicone Ties Clamp Covers IV poles Batrik non surgical shoe covers SafeFace Level 1 & 2 Isolation Gowns & Chemo Gowns-non-surgical Pin Mat Transport Bags for endoscopes & Instruments Stacking Step Stools SKINS PandaPatch Adhesive Eye Protector Valve Covers Couvrette Tourniquet Magnes-Mat Scrub Pads Corner Pockets Padlocks I.D. Roll/Sheet Tape Instrument Protectors

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2008-03-26
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	1996-06-06
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2023-10-04
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-07-16
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-06-30
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1996-06-06
FZM	Stool, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2019-12-04
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2007-03-12
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2024-11-12
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2019-12-04
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2007-03-12
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-09-25

Official Correspondent

Suzy Bairos

US Agent Details

Katie Doane Business: Tobias Systems LLC Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

BATRIK MEDICAL MANUFACTURING INC.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
3043473562	NADIA-HEALTH INC	Durham, NC, US
3038913749	INVENTEUR, LLC	Saint Petersburg, FL, US
3014926389	Jiangsu JianYu Health Medical Co., Ltd	Changzhou City Jiangsu, CN
3004930567	SUZHOU SUNING UNDERPAD CO., LTD.	SUZHOU, JIANGSU PROVINCE, CN
2529708	KRUSE TOOL & DIE, INC.	Warminster, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681702. Last updated year: 2026. Please use registration number 9681702 when referencing this establishment in official correspondence.