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Organization name
UDI-DI code
Reference / catalog number

BI 6 Comfort 1.5T — Class IIa MDR by NORAS MRI products GmbH

MD Atlas
NORAS MRI products GmbH

EUDAMED last updated this device on Mar 19, 2025

BI 6 Comfort 1.5T

42512692BREASTCOILBI6GG

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NORAS MRI products GmbH
UDI-DI code: 04251269206085
Reference / catalog number: 120385

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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.

CW029
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW025
EUDAMED did not publish a description for this code.
CW138
EUDAMED did not publish a description for this code.
CW036
EUDAMED did not publish a description for this code.
CW259
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Apr 29, 2021	Still on market

Device identification

Trade name: BI 6 Comfort 1.5T
UDI-DI code: 04251269206085
Basic UDI-DI: 42512692BREASTCOILBI6GG
Reference / catalog number: 120385
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

Related devices

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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.