Usine Rotec Inc

FDA Filings

This page includes the latest FDA filings for Usine Rotec Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number

3001752600

FEI Number

3001752600

Name

USINE ROTEC INC.

Owner & Operator

USINE ROTEC INC.

Contact Address

123 RUE DE L'EGLISE --
BAIE-DU-FEBVRE, QUEBEC CA-NOTA J0G 1A0 CA

Official Correspondent

Pineault - Kevin
1-450-7836444-229

US Agent

David Lennarz
Registrar Corp
757 2240177
757 2240179
david.lennarz@registrarcorp.com

Importing Logistics Registration

Importer	After the fall, inc.
Address	2239K Tacketts Mill Drive Woodbridge, VA 22192 UNITED STATES
Email Address	sid@atfmedical.com
Phone	1 703 4970333
FAX	1 703 4970377
Importer Type	Retailer

Importing Logistics Registration

Importer	Clinical Solution, JSC II
Address	1900 Schuetz Road Saint Louis, MO 63146 UNITED STATES
Email Address	tquinn@cs-clinicalsolutions.co
Phone	1 314 2913377
FAX	1 314 2913378
Importer Type	Retailer

Importing Logistics Registration

Importer	Clinical Synergy
Address	1225 S., Saddle Creek Rd Omaha, NE 68106 UNITED STATES
Email Address	mike@clinicalsynergy.com
Phone	1 402 2017301
Importer Type	Retailer

Importing Logistics Registration

Importer	Coler Rehabilitation and Nursing Care Center
Address	900 Main Street Roosevelt Island, NY 10044 UNITED STATES
Email Address	ari.sezanayev@Crothall.com
Phone	1 212 8486753
Importer Type	End User

Importing Logistics Registration

Importer	Department Veteran Affairs
Address	2121 North Ave Grand Junction VAMC Grand Junction, CO 81501 UNITED STATES
Phone	1 970 2420731 1360
Importer Type	End User

Importing Logistics Registration

Importer	Interior Fusion LLC
Address	7261 Bryan Dairy Road Largo, FL 33773 UNITED STATES
Phone	1 727 5175132
Importer Type	Sales & Rental

Importing Logistics Registration

Importer	Select Medical inc.
Address	4714 Gettysburg Road Mechanicsburg, PA 17055 UNITED STATES
Email Address	Ddorshimer@selectmedical.com
Phone	1 717 8847313
FAX	1 717 4097280
Importer Type	End User

Importing Logistics Registration

Importer	St. Cloud VA Health Care System
Address	4801 Veterans Dr Saint Cloud, MN 56303 UNITED STATES
Phone	1 320 2521670
Importer Type	End User

Registration Status

1

Initial Importer

N

Registration Expiration

2020-04-25

Registration Address

123 RUE DE L EGLISE
BAIE-DU-FEBVRE Quebec, J0G 1A0 CA

Establishment Type

Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID B303E042 Usine Rotec Inc	VersaTech 700 ULB+	2025-04-21
GUDID B303E041 Usine Rotec Inc	VersaTech 700 ULB+	2025-04-21
GUDID B303E040 Usine Rotec Inc	VersaTech 700 ULB	2025-04-21
GUDID B303E031 Usine Rotec Inc	VersaTech 600 ULB+	2025-04-21
GUDID B303E030 Usine Rotec Inc	VersaTech 600 ULB	2025-04-21
GUDID B303D042 Usine Rotec Inc	VersaTech 1100 ULB+	2025-04-21
GUDID B303D041 Usine Rotec Inc	VersaTech 1100 ULB+	2025-04-21
GUDID B303D040 Usine Rotec Inc	VersaTech 1100 ULB	2025-04-21
GUDID B303F0100 Usine Rotec Inc	VersaTech LB	2021-07-13
GUDID B303E0200 Usine Rotec Inc	VersaTech 600 ULB	2021-07-13
GUDID B303D0300 Usine Rotec Inc	VersaTech 1100 ULB	2021-07-13
GUDID B303B0100 Usine Rotec Inc	MultiTech ULB	2021-07-13
GUDID B303E0100 Usine Rotec Inc	Versatech 600 2.0	2018-03-29
GUDID B303E0000 Usine Rotec Inc	Versatech 600	2018-03-29
GUDID B303D0100 Usine Rotec Inc	Versatech 1100 2.0	2018-03-29
GUDID B303D0000 Usine Rotec Inc	Versatech 1100	2018-03-29
GUDID B303C0100 Usine Rotec Inc	Varitech 2.0	2018-03-29
GUDID B303C0000 Usine Rotec Inc	Varitech	2018-03-29
GUDID B303B0000 Usine Rotec Inc	Multitech 8	2018-03-29
GUDID B303A0000 Usine Rotec Inc	Multitech 2.0	2018-03-29
OSI USINE ROTEC INC.	Versatech 1100	2011-06-28
OSI USINE ROTEC INC.	Versatech 11 2.0	2011-06-28
OSI USINE ROTEC INC.	Varitech	2011-06-28
OSI USINE ROTEC INC.	Varitech 2.0	2011-06-28
FNL USINE ROTEC INC.	Versatech 600	2006-06-16
FNL USINE ROTEC INC.	Versatech 600 2.0	2006-06-16
FNL USINE ROTEC INC.	Versatech 1100	2006-06-16
FNL USINE ROTEC INC.	Versatech 1100 2.0	2006-06-16
FNL USINE ROTEC INC.	Varitech	2006-06-16
FNL USINE ROTEC INC.	Varitech 2.0	2006-06-16
FNL USINE ROTEC INC.	Multitech 8	2006-06-16
FNL USINE ROTEC INC.	Multitech 2.0	2006-06-16

Related Finance Registrations

NCAGE Code	8KSZ4	USINE ROTEC INC.
CAGE Code	8KSZ4	USINE ROTEC INC. ROTEC INTERNATIONAL
DUNS	117496382	USINE ROTEC INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092842426	Shanghai ,China (Mainland) -> Seattle, Washington	ADJUSTABLE BED	157 CTN
2020090292892	Shanghai ,China (Mainland) -> Long Beach, California	LOAD CELL	1 CTN
2020082296561	Algeciras,Spain -> Philadelphia, Pennsylvania	SIDE RAIL	1450 CTN
2020082169064	Algeciras,Spain -> Philadelphia, Pennsylvania	SIDE RAIL	1450 CTN
2019080356798	Ningpo ,China (Mainland) -> Tacoma, Washington	CONTROL BOX CABLE SIDE RAIL PLASTIC . .	651 CTN

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