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Organization name
UDI-DI code
Reference / catalog number

1085 ICS Impulse Incl. Lateral… — Class IIa MDR

MD Atlas
Natus Medical Denmark ApS

EUDAMED last updated this device on May 6, 2026

1085 ICS Impulse Incl. Lateral Head Impulse

5713315NA001014X

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Medical Denmark ApS
UDI-DI code: 05713315007149
Reference / catalog number: 8-04-16222

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Manufacturer information

Organization name: Natus Medical Denmark ApS
SRN: DK-MF-000001617
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.

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	May 18, 2026	Dec 31, 2099

Device identification

Trade name: 1085 ICS Impulse Incl. Lateral Head Impulse
UDI-DI code: 05713315007149
Basic UDI-DI: 5713315NA001014X
Reference / catalog number: 8-04-16222
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: 1085 ICS Impulse Incl. Lateral Head Impulse
Additional information URL: https://natus.com/support
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12120124VIDEO/ELECTRONYSTAGMOGRAPHS

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

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