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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

8-04-12118 — Class IIa MDR by Natus Medical Denmark ApS

MD Atlas
Natus Medical Denmark ApS

EUDAMED last updated this device on Oct 13, 2025

8-04-12118

5713315NA000385H

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Medical Denmark ApS
UDI-DI code: 05713315007477
Reference / catalog number: 8-04-12118

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View device family (Basic UDI)

Manufacturer information

Organization name: Natus Medical Denmark ApS
SRN: DK-MF-000001617
Manufacturer status: Active

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1047 Face Cushion5713315NA0003357On the market 1047, HEADSTRAP COMP5713315NA0003357On the market 1053 Freefit5713315NA000875WOn the market 1053 Freefit5713315NA000885YOn the market 1053 Freefit5713315NA000875WOn the market

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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	Oct 10, 2025	Dec 31, 2099

Device identification

Trade name: not provided
UDI-DI code: 05713315007477
Basic UDI-DI: 5713315NA000385H
Reference / catalog number: 8-04-12118
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: 1066 MADSEN Astera 2 without ACP ANSI Cal.Incl. ME70 Headset, Insert Earphone, NB71 BC
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05713315007477

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

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

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