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Organization name
UDI-DI code
Reference / catalog number

03, 13 — Class IIa MDR by Koite Health Oy

MD Atlas
Koite Health Oy

EUDAMED last updated this device on Jul 3, 2024

03, 13

6429810197LumoralClini66

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Koite Health Oy
UDI-DI code: 06429810197184
Reference / catalog number: 03, 13

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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: not provided
UDI-DI code: 06429810197184
Basic UDI-DI: 6429810197LumoralClini66
Reference / catalog number: 03, 13
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: Adult mouthpiece with connector 03 Adult widened mouthpiece with connector 13
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

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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.