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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

Kajo10 — Class I MDR by Kajo Apuvälineet Oy

MD Atlas
Kajo Apuvälineet Oy

EUDAMED last updated this device on Jan 19, 2023

Kajo10

6429810721Kajo10S7

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Kajo Apuvälineet Oy
UDI-DI code: 06429810721174
Reference / catalog number: K102023

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Manufacturer information

Organization name: Kajo Apuvälineet Oy
SRN: FI-MF-000002471
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: Kajo10
UDI-DI code: 06429810721174
Basic UDI-DI: 6429810721Kajo10S7
Reference / catalog number: K102023
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: Kajo Kymppi on elektroninen tablet-tietokone ja laaja puheentuoton apuväline, jonka tarkoituksena on avustaa henkilöä, jolla on synnynnäinen tai myöhemmin elämässä syntynyt puheen tuottamista rajoittava sairaus tai vamma. Kajo Kympin symboli- ja tekstipohjaisen kommunikointiohjelmiston avulla on tavoitteena edistää käyttäjän itsenäistä osallistumista jokapäiväisiin vuorovaikutustilanteisiin ja toimia puheentuoton kuntoutuksen apuvälineenä. Tuotteen keveys ja helppokäyttöisyys mahdollistavat sen kuljettamisen ja käytön monenlaisissa arjen vuorovaikutustilanteissa.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214209ALPHABETIC AND SYMBOLIC COMMUNICATORS

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

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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.