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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

52000001 — Class I MDR by Merz Medizintechnik GmbH

MD Atlas
Merz Medizintechnik GmbH

EUDAMED last updated this device on Feb 16, 2026

52000001

42605854142605854116844H

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Merz Medizintechnik GmbH
UDI-DI code: 04260585411745
Reference / catalog number: 52000001

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Manufacturer information

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

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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 Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04260585411745
Basic UDI-DI: 42605854142605854116844H
Reference / catalog number: 52000001
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: Bei dem Merz Drehstuhl handelt es sich um einen elektrisch angesteuerten Stuhl, der sinusförmige Bewegungen in der Horizontalen ausführt. Er kann über ein Modul der Software evidENT3 angesteuert werden. In Kombination mit einem VNG-System, das ein eigenes Medizinprodukt ist, kann der Drehstuhl für die Unterstützung bei Vestibularis-Untersuchungen in Kliniken genutzt werden. Der Drehstuhl ist eigenständig nutzbar. Zur Untersuchung der Augenbewegungen ist aber die Anbindung an die Software evidENT3 und der Anschluss eines VNG-Systems erforderlich. Merz Drehstuhl mit der Software evidENT3 ermöglicht die Durchführung aller relevanter Tests der Vestibularis-Untersuchung, wie Drehpendel-, Drehstop-, Rotations- und1 SHAT-Tests. Der Gebrauch erfolgt ausschließlich durch Audiologen, HNO-Ärzte, Arbeitsmediziner oder medizinisches Personal mit geeigneter Ausbildung oder Qualifikation und Einweisung. Der Merz Drehstuhl wird vom Computer über die USB-Schnittstelle angesteuert.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Winkelmaß

EMDN nomenclature code(s)

Z12140403ROTATING PENDULAR CHAIRS

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
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Software identification