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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

LUNAneo1arm — Class I MDR by Luna Cybernetics GmbH

MD Atlas
Luna Cybernetics GmbH

EUDAMED last updated this device on Oct 22, 2025

LUNAneo1arm

426075088NEOHX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Luna Cybernetics GmbH
UDI-DI code: 04260750880833
Reference / catalog number: 133-001

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Manufacturer information

Organization name: Luna Cybernetics GmbH
SRN: DE-MF-000024244
Manufacturer status: Active

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: LUNAneo1arm
UDI-DI code: 04260750880833
Basic UDI-DI: 426075088NEOHX
Reference / catalog number: 133-001
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: Die LUNAneo1 besitzt den medizinischen Zweck der Kompensierung zum Behinderungsausgleich von Arm- und Handfunktionsverlusten. Die LUNAneo1 ist damit gemäß der MDR 2017/745 ein Medizinprodukt. Dieses Medizinprodukt ist ausschließlich für die orthetische Versorgung der oberen Extremität zu verwenden. Die multiartikulierende myoelektrische und passive Funktionsweise der LUNAneo1 ermöglicht das Greifen, Drücken, Ziehen, Anheben, Halten und Tragen von Gegenständen.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060619ELBOW-WRIST-HAND ORTHOSES

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

Related devices

LUNAneo1grip426075088NEOHXOn the market LUNAneo1short426075088NEOHXOn 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.