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Organization name
UDI-DI code
Reference / catalog number

VIRON XO Illuminator (150 mm) — Class I MDR by Erbe Vision GmbH

MD Atlas
Erbe Vision GmbH

EUDAMED last updated this device on Jun 17, 2024

VIRON XO Illuminator (150 mm)

426021465XOIllUMINATOR6A

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Erbe Vision GmbH
UDI-DI code: 04260386576131
Reference / catalog number: 20821-004

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Manufacturer information

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

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Critical warnings

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

CW011
The VIRON XO illuminator must be always used with steril covers
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

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 XO Illuminator (150 mm)
UDI-DI code: 04260386576131
Basic UDI-DI: 426021465XOIllUMINATOR6A
Reference / catalog number: 20821-004
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: VIRON XO illuminator is intended to be used during open surgery to focus the light spot at the area of interest in such a way as to match it with view spot to be captured by the VIRON X camera head
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 150 MU50

EMDN nomenclature code(s)

Z12020480INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.