04-99-3.2-JJ1XXX

Trade name

not provided

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

View in glossary →

04260157780217

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

View in glossary →

B-04260157780217

Reference / catalog number

04-99-3.2-JJ1XXX

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

View in glossary →

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

View in glossary →

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The device RETI-port / scan 21 is used for function diagnostics in ophthalmology. It is designed to create visual stimuli and to measure and display the resulting electrophysiological signals from the retina and the visual nervous system. These tests are helpful for objective diagnosis of visual disorders. The following examinations can be carried out: ´ •Electroretinogram (ERG) •Visually evoked potentials (VEP) The control and analysis software runs under a Windows-based computer system.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 200–220 MU10
• 220–250 MU10
• 130–150 MU10

European Medical Device Nomenclature — the EU product classification assigned to this device.

• V030203OPHTHALMOLOGY MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES

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

• CW010

  Read IFU

No certificate specifically references this device's Basic UDI-DI.