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Organization name
UDI-DI code
Reference / catalog number

Lumoral Junior — Class IIa MDR by Koite Health Oy

MD Atlas
Koite Health Oy

EUDAMED last updated this device on Jul 3, 2024

Lumoral Junior

6429810197LumoralJunioB8

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Koite Health Oy
UDI-DI code: 06429810197191
Reference / catalog number: 21

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Manufacturer information

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

Market distribution

Primary placement in Finland; available across 2 countries total.

Country	On market since	Until
FinlandPrimary placement	Jun 1, 2022	Still on market
Sweden	Jun 1, 2022	Still on market

Device identification

Trade name: Lumoral Junior
UDI-DI code: 06429810197191
Basic UDI-DI: 6429810197LumoralJunioB8
Reference / catalog number: 21
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: 21 Junior mouthpiece
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
Serial number
Software identification

Related devices

N/A6429810197LumoralPowerbQ7On the market 036429810197LumoralClini66On the market 03, 136429810197LumoralClini66On the market 216429810197LumoralJunioB8On the market 216429810197LumoralJuniorP7On the market

Certificates

Certificate health across this manufacturer's portfolio.

FI25/00000056Issued
Quality management systemNotified body: 0598Expiry: Oct 6, 2028