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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

Madsen Zodiac SA Diagnostic w/o… — Class IIa MDR

MD Atlas
Natus Medical Denmark ApS

EUDAMED last updated this device on Apr 27, 2026

Madsen Zodiac SA Diagnostic w/o printer, Comfort probe

5713315NA001024Z

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Medical Denmark ApS
UDI-DI code: 05713315005633
Reference / catalog number: 8-04-16044

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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 22, 2026	Dec 31, 2099

Device identification

Trade name: Madsen Zodiac SA Diagnostic w/o printer, Comfort probe
UDI-DI code: 05713315005633
Basic UDI-DI: 5713315NA001024Z
Reference / catalog number: 8-04-16044
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: 1096 Zodiac SA Diagnostic w/o Printer and with Comfort Probe
Additional information URL: https://www.natussensory.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12149005IMPEDANCE METERS FOR THE AUDITORY SYSTEM

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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