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Organization name
UDI-DI code
Reference / catalog number

Magnes Nushu — Class IIa MDR by Effectum Medical AG

MD Atlas
Effectum Medical AG

EUDAMED last updated this device on Dec 4, 2025

Magnes Nushu

764025502Magnes-NuShuXY

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Effectum Medical AG
UDI-DI code: 07640255020564
Reference / catalog number: 010.001.010

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Manufacturer information

Organization name: Effectum Medical AG
SRN: CH-MF-000012474
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.

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW999
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of Magnes NUSHU, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result
CW999
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally
CW999
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
CW999
It is possible that high levels of interference due to close proximity or due to the power of a source, disrupts the operation of this device. Medical electrical devices require special precautions regarding electromagnetic compatibility and all devices must be installed and put into service in accordance with the information specified in this user manual.

Market distribution

Primary placement in Sweden; available across 3 countries total.

Country	On market since	Until
SwedenPrimary placement		Still on market
Germany		Still on market
Italy		Still on market

Device identification

Trade name: Magnes Nushu
UDI-DI code: 07640255020564
Basic UDI-DI: 764025502Magnes-NuShuXY
Reference / catalog number: 010.001.010
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: Magnes NUSHU is a medical device that enables patients to collect data on their gait and share this data with healthcare professionals (HCPs). Magnes NUSHU can help patients with gait deficits by providing them with notifications via vibrations on how they walk to assist normal walking. Magnes NUSHU allows to perform standard gait assessments and exercises. Magnes NUSHU Web Application is intended to be used by HCPs to visualize and track the walking parameters collected by patients using Magnes NUSHU. The data collected by Magnes NUSHU can be used to infer changes in the condition of patients.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y99DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - 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

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Expiration date
Manufacturing date
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Software identification