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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

X-Light — Class I MDR by Erbe Vision GmbH

MD Atlas
Erbe Vision GmbH

EUDAMED last updated this device on Jun 7, 2024

X-Light

426021465000IlluminateW8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Erbe Vision GmbH
UDI-DI code: 04260214650200
Reference / catalog number: 10820-001

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Manufacturer information

Organization name: Erbe Vision GmbH
SRN: DE-MF-000010268
Manufacturer status: Active

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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW036
The X-Light light source may only be connected to the VIRON X endoscopy camera control unit. Do not combine this light source with any other camera control or any other device.

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: X-Light
UDI-DI code: 04260214650200
Basic UDI-DI: 426021465000IlluminateW8
Reference / catalog number: 10820-001
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: Power frequency: 50 / 60 Hz System voltage: 100-240 V Potential equalization connection: yes IP-Class: IP20 Applied Part: Type CF
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12020402LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY

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

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