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Organization name
UDI-DI code
Reference / catalog number

51050010 — Class IIa MDR by Merz Medizintechnik GmbH

MD Atlas
Merz Medizintechnik GmbH

EUDAMED last updated this device on Feb 16, 2026

51050010

42605854142605854101993W

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Merz Medizintechnik GmbH
UDI-DI code: 04260585410250
Reference / catalog number: 51050010

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Manufacturer information

Organization name: Merz Medizintechnik GmbH
SRN: DE-MF-000010619
Manufacturer status: —

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260585410250
Basic UDI-DI: 42605854142605854101993W
Reference / catalog number: 51050010
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: Der Freifeldverstärker audiobox ist ein Zubehör zum Anschluss an ein Audiometer. Er ermöglicht es, bis zu 12 Lautsprecher über ein Audiometer anzusteuern und Ton- und Sprachsignale im Freifeld abzuspielen. Durch den universellen Anschluss kann der Freifeldverstärker audiobox an Audiometer unterschiedlicher Hersteller angebunden werden. Die audiobox wurde als Zubehör für das Audiometer MERZ Audio entwickelt, kann aber auch z.B. mit dem klinischen Audiometer Interacoustics Equinox verwendet werden. Der Freifeldverstärker audiobox ermöglicht es, Lautsprecher einzeln zu kalibrieren. Der Freifeldverstärker audiobox ist in einer 6-Kanal- und einer 12-Kanal-Variante erhältlich.
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
Serial number
Software identification

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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.