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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

Lou-Hi Rehab Cuff — Class I MDR by CareUs Oy

MD Atlas
CareUs Oy

EUDAMED last updated this device on Aug 13, 2025

Lou-Hi Rehab Cuff

06429830269809MD1LU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CareUs Oy
UDI-DI code: 06429830269809
Reference / catalog number: 10000

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Manufacturer information

Organization name: CareUs Oy
SRN: FI-MF-000047480
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: Lou-Hi Rehab Cuff
UDI-DI code: 06429830269809
Basic UDI-DI: 06429830269809MD1LU
Reference / catalog number: 10000
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: Kuntoutusmansettia voidaan käyttää yleisimpien fysioterapiassa käytettyjen kuntoutusharjoitusten tekemiseen. Laite tunnistaa kosketuksen ja yläraajojen, ranteen liikkeet ja sormien kosketuksen. Toistojen määrää pyritään lisäämään sovelluksen kautta tulevan ääni- ja musiikkipalautteen avulla.
Additional information URL: https://www.careus.fi/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12069080VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - HARDWARE ACCESSORIES

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

This device is not currently linked to any other device.

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.