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Organization name
UDI-DI code
Reference / catalog number

POLARIS 50 DVE — Class I MDR by Derungs Licht AG

MD Atlas
Derungs Licht AG

EUDAMED last updated this device on Aug 17, 2022

POLARIS 50 DVE

76401587128U

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Derungs Licht AG
UDI-DI code: 07640158711750
Reference / catalog number: D16087000

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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: POLARIS 50 DVE
UDI-DI code: 07640158711750
Basic UDI-DI: 76401587128U
Reference / catalog number: D16087000
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 fixed device intended to provide light to illuminate a site of patient treatment. 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. It can also be part of an operating light system consisting of more than one light head.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12010701FIXED SCIALYTIC LAMPS

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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