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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

NORAS OR HEAD COIL Bottom Array… — Class IIa MDR

MD Atlas
NORAS MRI products GmbH

EUDAMED last updated this device on Jul 30, 2025

NORAS OR HEAD COIL Bottom Array Siemens 1.5T

42512692HEADCOILJM

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NORAS MRI products GmbH
UDI-DI code: 04251269206788
Reference / catalog number: 114491

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Manufacturer information

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

Critical warnings

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

CW036
Combinable products enlisted in IFU.
CW029
IFU instructs to check for damages.
CW010
As indicated on the label.
CW138
The IFU must be read by each operator.
CW035
Use of infectors described in IFU.
CW018
As indicated on the label.
CW014
EUDAMED did not publish a description for this code.
CW259
Warning in IFU.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jul 17, 2025	Still on market

Device identification

Trade name: NORAS OR HEAD COIL Bottom Array Siemens 1.5T
UDI-DI code: 04251269206788
Basic UDI-DI: 42512692HEADCOILJM
Reference / catalog number: 114491
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)

Z11059080VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES

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

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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.