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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

Cart for Standard PC — Class I MDR by Natus Manufacturing…

MD Atlas
Natus Manufacturing Limited

EUDAMED last updated this device on May 2, 2024

Cart for Standard PC

038283NA00082EF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Manufacturing Limited
UDI-DI code: 00382830049405
Reference / catalog number: 9033B0721

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Manufacturer information

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

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: Cart for Standard PC
UDI-DI code: 00382830049405
Basic UDI-DI: 038283NA00082EF
Reference / catalog number: 9033B0721
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 Standard PC Cart facilitates movement of the Keypoint system, housing the desktop PC configuration with accessories needed to conduct EMG, NCS, or EP testing in clinical environments.
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
Expiration date
Manufacturing date
Serial number
Software identification

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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.