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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

Holder for Dantec DCN Disposable… — Class I MDR

MD Atlas
Natus Manufacturing Limited

EUDAMED last updated this device on May 2, 2024

Holder for Dantec DCN Disposable Concentric Needle Electrode

038283NA00012DS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Manufacturing Limited
UDI-DI code: 00382830047371
Reference / catalog number: 9013C0014

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Manufacturer information

Organization name: Natus Manufacturing Limited
SRN: IE-MF-000000799
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

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Ireland; available across 1 country total.

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

Device identification

Trade name: Holder for Dantec DCN Disposable Concentric Needle Electrode
UDI-DI code: 00382830047371
Basic UDI-DI: 038283NA00012DS
Reference / catalog number: 9013C0014
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: The Holder for Dantec DCN is an accessory cable available for use with the Dantec DCN Disposable Concentric Needle Electrodes. It connects the concentric needle to an amplifier during use to allow signal detection during medical procedures. The shielded reusable needle holder (cable) is provided non-sterile and is available individually.
Additional information URL: https://natus.com/support/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

N010101ELECTROMYOGRAPHIC ELECTRODES

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
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Software identification