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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

nordicAudio AccessPoint — Class I MDR by NordicNeuroLab AS

MD Atlas
NordicNeuroLab AS

EUDAMED last updated this device on Jan 30, 2025

nordicAudio AccessPoint

70900420530074

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NordicNeuroLab AS
UDI-DI code: 07090042053082
Reference / catalog number: 102125

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View device family (Basic UDI)

Manufacturer information

Organization name: NordicNeuroLab AS
SRN: NO-MF-000000555
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Norway; available across 1 country total.

Placed on the market in Norway; per-country availability dates not published.

Device identification

Trade name: nordicAudio AccessPoint
UDI-DI code: 07090042053082
Basic UDI-DI: 70900420530074
Reference / catalog number: 102125
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: AccessPoint for connecting the nordicAudio HeadSet to the nordicAudio AudioHub
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07090042053082

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z11020780INTEGRATED MRI/PET SYSTEMS - 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

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Control Room Interface (CRI)7090042052016ZOn the market InroomViewingDevice7090042051006SOn the market 2.07090042059218AOn the market nordicAktiva70900420592088On the market nordicAudio AudioHub70900420530074On the market

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.