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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

S12R — Class I MDR by Plusoptix GmbH

MD Atlas
Plusoptix GmbH

EUDAMED last updated this device on Oct 28, 2022

S12R

426018451x12HA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Plusoptix GmbH
UDI-DI code: 04260184513215
Reference / catalog number: S12R

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Manufacturer information

Organization name: Plusoptix GmbH
SRN: DE-MF-000006138
Manufacturer status: Active

Critical warnings

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

CW138
Please read user manual before using the device. It contains important information.
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.

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: not provided
UDI-DI code: 04260184513215
Basic UDI-DI: 426018451x12HA
Reference / catalog number: S12R
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: The plusoptiX 12 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/de-de/start
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q0299OPHTHALMIC DEVICES - OTHER

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

Related devices

A12C426018451x12HAOn the market A12R426018451x12HAOn the market A16426018451x16HJOn the market A20426018451x20H9On the market S12C426018451x12HAOn the market

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.