Roll Belt Large

Organization name

RENOL

SRN

BE-MF-000000785

Manufacturer status

Active

Primary placement in Belgium; available across 12 countries total.

Trade name

Roll Belt Large

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.

05407009800283

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.

540700980BELT83

Reference / catalog number

RFB10140M

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

with Magnet Locks

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Large

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

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

• V0804PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)

• Class I medical devices in EUDAMED

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