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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

Breast Basis Set — Class IIa MDR by NORAS MRI products GmbH

MD Atlas
NORAS MRI products GmbH

EUDAMED last updated this device on Mar 19, 2025

Breast Basis Set

42512692BREASTCOIL4CHEX

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NORAS MRI products GmbH
UDI-DI code: 04251269200151
Reference / catalog number: 112422

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Manufacturer information

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

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
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.
CW029
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	May 18, 2022	Still on market

Device identification

Trade name: Breast Basis Set
UDI-DI code: 04251269200151
Basic UDI-DI: 42512692BREASTCOIL4CHEX
Reference / catalog number: 112422
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.