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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

Foam Ear Tips — Class I MDR by Natus Medical Denmark ApS

MD Atlas
Natus Medical Denmark ApS

EUDAMED last updated this device on Dec 12, 2025

Foam Ear Tips

5713315NA001075B

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Medical Denmark ApS
UDI-DI code: 05713315009310
Reference / catalog number: 80A4821000

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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.

Placed on the market in Denmark; per-country availability dates not published.

Device identification

Trade name: Foam Ear Tips
UDI-DI code: 05713315009310
Basic UDI-DI: 5713315NA001075B
Reference / catalog number: 80A4821000
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: Foam Eartip, 3B (Small) (bag of 50 pcs)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z121401AUDIOMETERS

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
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Software identification