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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

Kinesis Balance — Class I MDR by Linus Health Europe

MD Atlas
Linus Health Europe

EUDAMED last updated this device on Nov 23, 2022

Kinesis Balance

539154295BalanceJW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Linus Health Europe
UDI-DI code: 53915429500272
Reference / catalog number: Balance

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Manufacturer information

Organization name: Linus Health Europe
SRN: IE-MF-000020900
Manufacturer status: Active

Market distribution

Primary placement in Ireland; available across 1 country total.

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

Device identification

Trade name: Kinesis Balance
UDI-DI code: 53915429500272
Basic UDI-DI: 539154295BalanceJW
Reference / catalog number: Balance
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: Balance is intended to measure static balance, leg strength and endurance as well as falls risk using a COTS smartphone device.
Additional information URL: https://kinesis.ie/balance/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

Kinesis Gait539154295GAITEROn the market Kinesis QTUG539154295QTUGL8On 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.