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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 1 Camera head — Class I MDR by Erbe Vision GmbH

MD Atlas
Erbe Vision GmbH

EUDAMED last updated this device on Jun 17, 2024

VIRON 1 Camera head

426021465000Camera8D

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Erbe Vision GmbH
UDI-DI code: 04260214650057
Reference / catalog number: 10801-002

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Manufacturer information

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

Critical warnings

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

CW133
To guarantee the safety of the user, the patient and others, use only accessories and spare parts specified by the manufacturer of this product. Other accessories or spare parts can cause the emission of increased electromagnetic radiation or reduced immunity against interference.
CW011
"Do not operate this device in areas where there is a danger of explosion. The device is not intended to be used in an oxygen rich environment."
CW014
EUDAMED did not publish a description for this code.

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 1 Camera head
UDI-DI code: 04260214650057
Basic UDI-DI: 426021465000Camera8D
Reference / catalog number: 10801-002
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: camera head with CMOS and 3 programmable buttons
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12020405SURGICAL CAMERAS

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.