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Organization name
UDI-DI code
Reference / catalog number

iLoop Interventional Coil 0.55T — Class IIa MDR

MD Atlas
NORAS MRI products GmbH

EUDAMED last updated this device on Apr 30, 2024

iLoop Interventional Coil 0.55T

42512692ILOOPCOIL055PW

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NORAS MRI products GmbH
UDI-DI code: 04251269207297
Reference / catalog number: 121048

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Manufacturer information

Organization name: NORAS MRI products GmbH
SRN: DE-MF-000006182
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW999
Wrong diagnosis due to artefacts: Artefacts could lead to wrong diagnosis. Make sure the staff operating the device is sufficiently trained. Do not use the device if you observe obvious imaging artefacts (for example: increased noise or zipper artefacts).
CW999
MRI procedures that include the evaluated device will be conducted for clinical purposes at the discretion of the ordering physician.
CW035
Do not use other disinfectants than specified in the disinfection procedure. The surface of the product might otherwise get damaged.
CW999
Do not leave the coil lying in the MR-scanner during the scan-process, if it is not connected.
CW999
Do not stack multiple receive coil onto the patient. Do not let receive coils overlap with this device. If stacking or overlapping should however be needed observe the behaviour of the device and check it is working as intended.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 13, 2024	Still on market

Device identification

Trade name: iLoop Interventional Coil 0.55T
UDI-DI code: 04251269207297
Basic UDI-DI: 42512692ILOOPCOIL055PW
Reference / catalog number: 121048
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11059099VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification