Question 1

What types of medical devices does Usine Rotec Inc manufacture?

Accepted Answer

Usine Rotec Inc specializes in basic electric hospital beds, including standard adjustable models and bariatric beds designed for patients requiring higher weight support. Their product line features ultra-low bed frames and specialized medical-surgical beds, such as the VersaTech series, which offer adjustable positioning for patient comfort and care.

Question 2

Where is Usine Rotec Inc based?

Accepted Answer

Usine Rotec Inc is headquartered in Canada, where it develops and manufactures its range of hospital bed products. The company operates within Canadian regulatory frameworks while also ensuring compliance with international standards for medical devices.

Question 3

Which regulatory registries list Usine Rotec Inc’s devices?

Accepted Answer

Usine Rotec Inc’s devices are listed in the EU’s EUDAMED database and the FDA’s Unique Device Identification (UDI) system, ensuring traceability and transparency for regulatory and market surveillance purposes. These registries help healthcare providers and authorities verify device details and compliance.

Question 4

How are Usine Rotec Inc’s hospital beds classified under medical device regulations?

Accepted Answer

Usine Rotec Inc’s devices fall under Class I and Class II classifications, depending on their features and intended use. Class I devices are generally low-risk, non-invasive products like basic hospital beds, while Class II devices may include those with additional controls or specialized functions, such as bariatric or medical-surgical beds, requiring stricter regulatory oversight.

Device	Model / Reference	Registries	Class	Status
VersaTech 1100 ULB	V11ULB	FDA UDI	Class II	Active
Multitech 2.0	MT2.0	FDA UDI	Class II	Unknown
Varitech	Varitech	FDA UDI	Class II	Unknown
Versatech 600 2.0	V600 2.0	FDA UDI	Class II	Unknown
VersaTech 700 ULB+	V7ULB+-xx-1010	FDA UDI	Class II	Active
VersaTech 600 ULB	V600ULB	FDA UDI	Class II	Active
VersaTech 1100 ULB+	V11ULB+-xx-1010	FDA UDI	Class II	Active
Varitech 2.0	Varitech 2.0	FDA UDI	Class II	Unknown
VersaTech 1100 ULB+	V11ULB+-xx-1110	FDA UDI	Class II	Active
VersaTech 600 ULB+	V6ULB+-xx-1010	FDA UDI	Class II	Active
Versatech 600	V600	FDA UDI	Class II	Unknown
VersaTech 700 ULB+	V7ULB+-xx-1110	FDA UDI	Class II	Active
Versatech 1100	V1100	FDA UDI	Class II	Unknown
Multitech 8	MT8	FDA UDI	Class II	Unknown
VersaTech 600 ULB	V6ULB+-xx-1000	FDA UDI	Class II	Active
VersaTech 700 ULB	V7ULB+-xx-1000	FDA UDI	Class II	Active
VersaTech 1100 ULB	V11ULB+-xx-1000	FDA UDI	Class II	Active
VersaTech LB	VLB	FDA UDI	Class II	Unknown
MultiTech ULB	MTULB	FDA UDI	Class II	Unknown
Versatech 1100 2.0	V1100 2.0	FDA UDI	Class II	Unknown
VersaTech Bariatric 1100	V11ULB+-EU-1010	EUDAMED	Class I	Active
VersaTech Med-Surg XL 700	V7ULB+-EU-1110	EUDAMED	Class I	Active
VersaTech Med-Surg XL 700	V7ULB+-EU-1000	EUDAMED	Class I	Active
VersaTech Med-Surg XL 700	V7ULB+-EU-1010	EUDAMED	Class I	Active
VersaTech Med-Surg 600	V6ULB+-EU-1000	EUDAMED	Class I	Active
VersaTech Bariatric 1100	V11ULB+-EU-1110	EUDAMED	Class I	Active
VersaTech Bariatric 1100	V11ULB+-EU-1000	EUDAMED	Class I	Active
Versatech 1100 ULB with Scale	V11ULB-xx-1000	EUDAMED	Class I	Active

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