Organization name

Usine Rotec Inc.

SRN

CA-MF-000022549

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use
• Caution

  Check for adequate mattress specifications and make sure that before lowering no body parts of the patient are all above the mattress.

Primary placement in Czechia; available across 32 countries total.

Trade name

not provided

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

07540161720414

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

754016172V11ULB+5N

Reference / catalog number

V11ULB+-EU-1000

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

VersaTech 1100 ULB+ Bariatric bed with scale

Additional information URL

https://rotecbeds.com/en/products/versatech-1100-ulb

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• V08060106BARIATRIC ELECTRIC MEDICAL BEDS
• V08060105ELECTRIC MEDICAL BEDS WITH WEIGHING SYSTEM

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.