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Organization name
UDI-DI code
Reference / catalog number

HALUX N50-1 P FX — Class I MDR by Derungs Licht AG

MD Atlas
Derungs Licht AG

EUDAMED last updated this device on Aug 17, 2022

HALUX N50-1 P FX

76401587118S

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Derungs Licht AG
UDI-DI code: 07640158711118
Reference / catalog number: D16012000

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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 Germany; available across 1 country total.

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

Device identification

Trade name: HALUX N50-1 P FX
UDI-DI code: 07640158711118
Basic UDI-DI: 76401587118S
Reference / catalog number: D16012000
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: A device intended to provide light to illuminate a site of patient examination. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount or with pin connection.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z129004LIGHT SOURCES

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

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Manufacturing date
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