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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

OAE EarTips — Class I MDR by Natus Medical Denmark ApS

MD Atlas
Natus Medical Denmark ApS

EUDAMED last updated this device on Apr 30, 2026

OAE EarTips

5713315NA001104Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Medical Denmark ApS
UDI-DI code: 05713315012150
Reference / catalog number: 203219

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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	Apr 30, 2026	Dec 31, 2099

Device identification

Trade name: OAE EarTips
UDI-DI code: 05713315012150
Basic UDI-DI: 5713315NA001104Y
Reference / catalog number: 203219
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: OAE Preemie Tree Tip (100)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z129013GENERAL AUDITORY AND/OR VISUAL STIMULATORS

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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Software identification