04-99-3.2-JJ0XXX

Organization name

Roland Consult Stasche & Finger GmbH

SRN

DE-MF-000021413

Manufacturer status

Active

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

• CW010

  Read IFU

Primary placement in Austria; available across 25 countries total.

Trade name

not provided

UDI-DI code

04260157780200

Basic UDI-DI

B-04260157780200

Reference / catalog number

04-99-3.2-JJ0XXX

Issuing entity

GS1

Risk category

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

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

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• V030203OPHTHALMOLOGY MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES