Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006535976

FEI Number

3006535976

Entity Name

FIBERLINKS TEXTILES INC.

City/State/Country

Saint Laurent Quebec, CA

Establishment Address

5800 Rue Kieran, Saint Laurent Quebec H4S 2B5, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

FIBERLINKS TEXTILES INC. (Owner Number: 9098519)

Owner / Operator Contact Address

5800 Rue Kieran, --, Saint-Laurent, CA-QC H4S 2B5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ISOLATION GOWN; REUSABLE ISOLATION GOWN incontinence garment Breeze; Patient transfer device; PTD DEVICE, TRANSFER, PATIENT, MANUAL fiber

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2023-12-13
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2011-04-06
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2023-12-13
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2011-04-06

Official Correspondent

Ryan Van rees

US Agent Details

MICHELLE GARROW Business: Metro Customs Brokers inc. Email: fib18489@metrocb.com Phone: (518) 2973000

Related Public Records

Same Entity

FIBERLINKS TEXTILES INC.

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 3006535976. Last updated year: 2026. Please use registration number 3006535976 when referencing this establishment in official correspondence.