Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001752600

FEI Number

3001752600

Entity Name

USINE ROTEC INC.

City/State/Country

BAIE-DU-FEBVRE Quebec, CA

Establishment Address

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

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

USINE ROTEC INC. (Owner Number: 9088679)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Versatech 11 2 Versatech 1100 Varitech Varitech 2 VersaTech 1100 ULB VersaTech Bariatric VersaTech 1100 ULB+ Versatech 600 Versatech 600 2 Varitech Varitech 2 Multitech 8 Versatech 1100 Versatech 1100 2 Multitech 2 VersaTech 600 ULB MultiTech ULB VersaTech LB VersaTech 1100 ULB VersaTech 1100 ULB+ VersaTech 700 ULB VersaTech Med-Surg XL VersaTech 600 ULB+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OSI	Bariatric Bed	General Hospital	Class 2	880.5100	2011-06-28
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2006-06-16

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

USINE ROTEC INC.

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
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

Similar Registrations

Registration Number	Establishment Name	Location
3010034871	VITALGO INC.	Miramar, FL, US
3006795832	Hangzhou Dunli Medical Instruments Co.,Ltd	Hangzhou Zhejiang, CN
3006206434	GENTEEL HOMECARE PRODUCTS CO., LTD.	FOSHAN Guangdong, CN
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US
3008951110	NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., LTD.	Rugao Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001752600. Last updated year: 2026. Please use registration number 3001752600 when referencing this establishment in official correspondence.