Organization name

Enclara Medical s.r.l.

SRN

IT-MF-000013110

Manufacturer status

Active

Primary placement in Italy; available across 32 countries total.

Trade name

CRM 001 6C - Carrello risonanza magnetica 6 cassetti

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.

08053307710327

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.

8053307711109S

Reference / catalog number

CRM 001 6C

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

The CRM 001 non-magnetic trolley is designed for the transport and distribution of medicines, dressings, instruments and various materials in an MRI environment. It is made entirely of non-metallic, non-magnetic and electrically non-conductive materials. For this reason it can be labeled as MR Safe according to the harmonized standard CEI EN 62570:2016-01.

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Z1105018099MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER

• Class I medical devices in EUDAMED

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