A20

Organization name

Plusoptix GmbH

SRN

DE-MF-000006138

Manufacturer status

Active

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

• CW011

  The device may not be opened. Opening the device runs the risk of receiving an (invisible) electric shock, and it will invalidate its approval as a medical device.
• CW138

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Trade name

not provided

UDI-DI code

04260184515110

Basic UDI-DI

426018451x20H9

Reference / catalog number

A20

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The plusoptiX A20 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.

Additional information URL

https://www.plusoptix.com/

Clinical sizes

No clinical sizes registered for this device.

• Q0299OPHTHALMIC DEVICES - OTHER

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