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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

Tremor Sensor — Class I MDR by Natus Manufacturing…

MD Atlas
Natus Manufacturing Limited

EUDAMED last updated this device on May 2, 2024

Tremor Sensor

038283NA00084EK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Manufacturing Limited
UDI-DI code: 00382830047746
Reference / catalog number: 9013L0241

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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: Tremor Sensor
UDI-DI code: 00382830047746
Basic UDI-DI: 038283NA00084EK
Reference / catalog number: 9013L0241
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 Tremor Sensor is a device used to record the characteristics of tremor movements for the monitoring and evaluation of neurologic function.
Additional information URL: https://natus.com/support/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12100480ELECTROMYOGRAPHY INSTRUMENTS - 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

UDI-PI traceability

Batch number
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Manufacturing date
Serial number
Software identification