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Organization name
UDI-DI code
Reference / catalog number

neoBLUE Radiometer — Class I MDR by Derungs Licht AG

MD Atlas
Derungs Licht AG

EUDAMED last updated this device on Aug 17, 2023

neoBLUE Radiometer

76401587148Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Derungs Licht AG
UDI-DI code: 07640158712146
Reference / catalog number: D162136000

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Manufacturer information

Organization name: Derungs Licht AG
SRN: CH-MF-000015827
Manufacturer status: Active

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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.

Market distribution

Primary placement in Ireland; available across 1 country total.

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

Device identification

Trade name: neoBLUE Radiometer
UDI-DI code: 07640158712146
Basic UDI-DI: 76401587148Y
Reference / catalog number: D162136000
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: The blue light radiometers (neoBLUE radiometer) are a battery-powered handheld devices for measuring the irradiance in the spectral range from 420 to 500 nm in hyperbilirubinemia treatments in newborns and infants. The measuring range of the blue light radiometer can be adjusted to the therapeutic spectrum of the phototherapy devices by using optical filters. The blue light radiometers can therefore be factory calibrated in different spectral ranges within the 420 to 500 nm. These phototherapy devices work with different wavelengths and wavelength ranges (therapeutic spectrum), which according to IEC 60601-2-50 are always within the wavelength of 400-550 nm.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0380DEVICES WITH MEASURING FUNCTIONS - 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

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