NEOS-01

Organization name

machineMD AG

SRN

CH-MF-000041378

Manufacturer status

Active

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

• CW999

  Contraindication: Refractive error beyond the level that can be corrected by the system, which is from -6 to +4 dioptres.
• CW999

  Contraindication: A medical opinion is required prior to use in case of an injury, wounds) or lesions to the head and the face
• CW999

  Contraindication: The device is not intended to measure ocular alignment during the preparation of a strabismus surgery, without the confirmation of the strabismus angles by another measurement method.

Primary placement in Germany; available across 4 countries total.

Trade name

not provided

UDI-DI code

07649989541017

Basic UDI-DI

7649989541-neos-0XX-F5

Reference / catalog number

NEOS-01

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

neos is a reusable medical device system, that presents visual stimuli to both eyes individually, and measures the resulting eye movements and pupillary changes of each eye. The intended use of neos is to support diagnosis and monitoring of neuro-ophthalmic conditions based on the neos examinations

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12120199OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER

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

This device is not currently linked to any other device.