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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

21 — Class I MDR by Koite Health Oy

MD Atlas
Koite Health Oy

EUDAMED last updated this device on Feb 9, 2023

21

6429810197LumoralJuniorP7

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Koite Health Oy
UDI-DI code: 06429810197085
Reference / catalog number: 21

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Manufacturer information

Organization name: Koite Health Oy
SRN: FI-MF-000006901
Manufacturer status: Active

Related devices

N/A6429810197LumoralPowerbQ7On the market 036429810197LumoralClini66On the market 03, 136429810197LumoralClini66On the market 216429810197LumoralJunioB8On the market Lumoral Junior6429810197LumoralJunioB8On 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.

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: not provided
UDI-DI code: 06429810197085
Basic UDI-DI: 6429810197LumoralJuniorP7
Reference / catalog number: 21
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: 21 Junior without connector
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040202PHOTOTHERAPY EQUIPMENT

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
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Software identification