Organization name

Medical Innovation Design MID AB

SRN

SE-MF-000053189

Manufacturer status

Active

Primary placement in Sweden; available across 15 countries total.

Trade name

Sidemarker MRI/Left

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.

07350132811979

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.

735013281SM01/02VX

Reference / catalog number

17

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

Labeling calibration, MRI compatible products Sidemarker MRI/Left - Art.nr: SM02-02 Side confusion is a common problem in healthcare. According to the recommendations of the Swedish National Board of Health and Welfare, some type of marking should therefore be introduced into the gantry of the MRI camera to subsequently be able to distinguish the right and left sides in the images.

Additional information URL

https://www.mid.nu/produkter/sidemarker-mrileft-artnr-sm02-02

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.

• Z11059099VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER

• Class I medical devices in EUDAMED

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