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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

Reusable HushTM Shielded Digital… — Class I MDR

MD Atlas
Natus Manufacturing Limited

EUDAMED last updated this device on May 2, 2024

Reusable HushTM Shielded Digital Ring Electrode

0382830059183UC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Manufacturing Limited
UDI-DI code: 00382830047913
Reference / catalog number: 9013S0302

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Manufacturer information

Organization name: Natus Manufacturing Limited
SRN: IE-MF-000000799
Manufacturer status: Active

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: Reusable HushTM Shielded Digital Ring Electrode
UDI-DI code: 00382830047913
Basic UDI-DI: 0382830059183UC
Reference / catalog number: 9013S0302
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: Reusable EMG Shielded Digital Ring Electrodes are used to assess the propagation properties of normal and diseased nerves. Electrodes are expected to maintain a continuous connection for monitoring electromyogenic and physiologic data signals.
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
Serial number
Software identification

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