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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

1053 Freefit — Class I MDR by Natus Medical Denmark ApS

MD Atlas
Natus Medical Denmark ApS

EUDAMED last updated this device on May 8, 2026

1053 Freefit

5713315NA000885Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Medical Denmark ApS
UDI-DI code: 05713315003318
Reference / catalog number: 8-62-39400

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Manufacturer information

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

Related devices

1053 Freefit5713315NA000875WOn the market 1053 Freefit5713315NA000875WOn the market 1053 Freefit5713315NA000875WOn the market 1053 Freefit5713315NA000875WOn the market 1053 Freefit5713315NA000885YOn 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.

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	May 8, 2026	Dec 31, 2099

Device identification

Trade name: 1053 Freefit
UDI-DI code: 05713315003318
Basic UDI-DI: 5713315NA000885Y
Reference / catalog number: 8-62-39400
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: 50
Additional product description: 1053 Freefit REM tube
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214599HEARING AIDS - OTHER

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