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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

Flex Arm with Clamp — Class I MDR by Natus Manufacturing…

MD Atlas
Natus Manufacturing Limited

EUDAMED last updated this device on May 2, 2024

Flex Arm with Clamp

038283NA00081ED

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Manufacturing Limited
UDI-DI code: 00382830049436
Reference / catalog number: 9033B0761

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Manufacturer information

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

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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: Flex Arm with Clamp
UDI-DI code: 00382830049436
Basic UDI-DI: 038283NA00081ED
Reference / catalog number: 9033B0761
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 Flex Arm with Clamp is a convenient option to mount an amplifier to a sturdy horizontal surface, such as a desk or tabletop. The 40cm moveable arm facilitates positioning of the amplifier for the user.
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

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.