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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

VIRON X Camera control unit — Class I MDR by Erbe Vision GmbH

MD Atlas
Erbe Vision GmbH

EUDAMED last updated this device on Jun 17, 2024

VIRON X Camera control unit

426021465000Camera8D

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Erbe Vision GmbH
UDI-DI code: 04260386576216
Reference / catalog number: 10800-006

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Manufacturer information

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

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW133
The supply voltage must match the voltage specified on the rating plate. Connect the unit / the equipment cart to a properly installed grounded outlet. Only use the Erbe power cord or an equivalent power cord for this purpose. The power cord must bear the national test symbol. For safety reasons, multiple outlets and extension cords should not be used. If their use is unavoidable, they also must be provided with proper grounding
CW999
Type CF applied part

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: VIRON X Camera control unit
UDI-DI code: 04260386576216
Basic UDI-DI: 426021465000Camera8D
Reference / catalog number: 10800-006
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 VIRON X endoscopy camera system is used for comprehensive visualization during endoscopic or exoscopic diagnosis and interventions in medicine. The camera accepts standard C- mount lenses and outputs standard video signals which can connect to a standard video monitor or a video capture frame grabber of a computer-based imaging system. VIRON X provides real-time endoscopic or exoscopic imaging in the visible and near infrared (NIR) range (810-900nm wavelength) vision using special light source designed by manufacturer
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12020403MODULES FOR ENDOSCOPIC IMAGING 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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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.